Home medical device systems and methods for therapy prescription and tracking, servicing and inventory

ABSTRACT

A home medical device system includes a plurality of home therapy machines that perform a home therapy on a patient; a connectivity server; a system hub coupled to the home therapy machines through the connectivity server; a web portal configured to access the system hub; a plurality of clinics connected to the system hub via the web portal; and a website accessible via the web portal, the website including a patient portion available to patients using the plurality of home therapy machines, the website further including a clinician portion that enables the clinics to manage the home therapy machines.

PRIORITY CLAIM

This application claims priority to U.S. Patent Application Ser. No.61/647,340, entitled “HOME MEDICAL DEVICE SYSTEMS AND METHODS FORTHERAPY PRESCRIPTION AND TRACKING, SERVICING AND INVENTORY”, filed May15, 2012, the entire contents of which are incorporated herein byreference and relied upon.

CROSS REFERENCE TO COMMONLY OWNED RELATED PATENTS AND APPLICATIONS

This patent application is related to U.S. patent application Ser. No.12/170,184 filed Jul. 9, 2008 (now U.S. Pat. No. 7,981,281), U.S. patentapplication Ser. No. 12/170,172 filed Jul. 9, 2008 (now U.S. Pat. No.8,168,063), U.S. patent application Ser. No. 12/170,204 filed Jul. 9,2008 (published on Jan. 14, 2010 as U.S. Patent Publication No.2010/0010426), U.S. patent application Ser. No. 13/274,012 filed Oct.14, 2011 (now U.S. Pat. No. 8,313,642), which is a continuation of U.S.patent application Ser. No. 12/170,220 filed Jul. 9, 2008 (now U.S. Pat.No. 8,057,679), U.S. patent application Ser. No. 13/251,901 filed Oct.3, 2011 (now U.S. Pat. No. 8,257,582), which is a continuation of U.S.patent application Ser. No. 12/170,230 filed Jul. 9, 2008 (now U.S. Pat.No. 8,062,513), and U.S. Patent Application Ser. No. 61/647,340 filedMay 15, 2012, the contents of each of which are herein incorporated byreference in their entirety and relied upon.

BACKGROUND

The present disclosure relates generally to renal therapy systems andmore specifically to systems and methods for prescribing, tracking,servicing and organizing home medical devices.

Due to disease, insult or other causes, a person's renal system canfail. In renal failure of any cause, there are several physiologicalderangements. The balance of water, minerals and the excretion of dailymetabolic load is no longer possible in renal failure. During renalfailure, toxic end products of nitrogen metabolism (urea, creatinine,uric acid, and others) can accumulate in blood and tissues.

Kidney failure and reduced kidney function have been treated withdialysis. Dialysis removes waste, toxins and excess water from the bodythat would otherwise have been removed by normal functioning kidneys.Dialysis treatment for replacement of kidney functions is critical tomany people because the treatment is life saving. One who has failedkidneys could not continue to live without replacing at least thefiltration functions of the kidneys.

Hemodialysis and peritoneal dialysis are two types of dialysis therapiescommonly used to treat loss of kidney function. Hemodialysis treatmentuses the patient's blood to remove waste, toxins and excess water fromthe patient. The patient is connected to a hemodialysis machine and thepatient's blood is pumped through the machine. Catheters are insertedinto the patient's veins and arteries to connect the blood flow to andfrom the hemodialysis machine. As blood passes through a dialyzer in thehemodialysis machine, the dialyzer removes the waste, toxins and excesswater from the patient's blood and returns the blood back to thepatient. A large amount of dialysate, for example about one-hundredtwenty liters, is used to dialyze the blood during a single hemodialysistreatment. The spent dialysate is then discarded. Hemodialysis treatmentlasts several hours and is generally performed in a treatment centerabout three or four times per week.

Peritoneal dialysis uses a dialysis solution or “dialysate”, which isinfused into a patient's peritoneal cavity through a catheter implantedin the cavity. The dialysate contacts the patient's peritoneal membranein the peritoneal cavity. Waste, toxins and excess water pass from thepatient's bloodstream through the peritoneal membrane and into thedialysate. The transfer of waste, toxins, and water from the bloodstreaminto the dialysate occurs due to diffusion and osmosis, i.e., an osmoticgradient occurs across the membrane. The spent dialysate drains from thepatient's peritoneal cavity and removes the waste, toxins and excesswater from the patient. This cycle is repeated.

There are various types of peritoneal dialysis therapies, includingcontinuous ambulatory peritoneal dialysis (“CAPD”), automated peritonealdialysis and continuous flow peritoneal dialysis. CAPD is a manualdialysis treatment, in which the patient connects an implanted catheterto a drain and allows a spent dialysate fluid to drain from theperitoneal cavity. The patient then connects the catheter to a bag offresh dialysate and manually infuses fresh dialysate through thecatheter and into the patient's peritoneal cavity. The patientdisconnects the catheter from the fresh dialysate bag and allows thedialysate to dwell within the cavity to transfer waste, toxins andexcess water from the patient's bloodstream to the dialysate solution.After a dwell period, the patient repeats the manual dialysis procedure.

In CAPD the patient performs several drain, fill, and dwell cyclesduring the day, for example, about four times per day. Each treatmentcycle typically takes about an hour. Manual peritoneal dialysisperformed by the patient requires a significant amount of time andeffort from the patient. This inconvenient procedure leaves ample roomfor improvement and therapy enhancements to improve patient quality oflife.

Automated peritoneal dialysis (“APD”) is similar to CAPD in that thedialysis treatment includes a drain, fill, and dwell cycle. APDmachines, however, automatically perform three to four cycles ofperitoneal dialysis treatment, typically overnight while the patientsleeps. The APD machines fluidly connect to an implanted catheter. TheAPD machines also fluidly connect to a source or bag of fresh dialysateand to a fluid drain.

The APD machines pump fresh dialysate from the dialysate source, throughthe catheter, into the patient's peritoneal cavity and allow thedialysate to dwell within the cavity so that the transfer of waste,toxins and excess water from the patient's bloodstream to the dialysatesolution can take place. The APD machines then pump spent dialysate fromthe peritoneal cavity, though the catheter, to the drain. APD machinesare typically computer controlled so that the dialysis treatment occursautomatically when the patient is connected to the dialysis machine, forexample, when the patient sleeps. That is, the APD systems automaticallyand sequentially pump fluid into the peritoneal cavity, allow for adwell, pump fluid out of the peritoneal cavity and repeat the procedure.

As with the manual process, several drain, fill, and dwell cycles willoccur during APD. A “last fill” is typically used at the end of APD,which remains in the peritoneal cavity of the patient when the patientdisconnects from the dialysis machine for the day. APD frees the patientfrom having to manually perform the drain, dwell, and fill steps.

For patients suffering from renal diseases, frequent dialysis is a wayof life. Most peritoneal dialysis patients perform dialysis once a day.Hemodialysis patients typically require dialysis several times a week.To allow patients to continue to live their lives as normally aspossible, there has been an increased desire to provide home dialysissolutions. Peritoneal dialysis is typically performed at home.Hemodialysis and other blood treatment therapies, such ashemofiltration, are performed largely in centers and clinics.

Performing hemodialysis at home presents more challenges and complexitythan peritoneal dialysis because blood is actually removed from apatient for cleaning. Hemodialysis may require a water treatment systemto prepare dialysate online. Home hemodialysis may also require someform of patient supervision. Home hemodialysis can also be complicatedby the fact that the patient's treatment prescription may change overtime and that patients may have multiple treatment prescriptions. Also,consumables used in hemodialysis can be expensive. Their use, efficacyand inventory should be tightly monitored. Hemodialysis machines mayalso require maintenance or service from a skilled technician. It isthus desirable to have a way to manage service calls to a patient's hometo keep the machines running correctly. A schedule may also be neededfor the delivery of the necessary consumables without delivering morethan needed and risking waste of consumables.

It is desirable to transfer the results of treatment for both homeperitoneal dialysis and hemodialysis. The results should be accurate,timely and provide the level of detail that clinicians expect fromin-clinic therapies. It is also desirable for clinicians to modifyprescriptions.

A need accordingly exists for a home dialysis system, for bothperitoneal dialysis and hemodialysis, that provides at least some of theabove-described features.

SUMMARY

The present system and method involve a medical device infrastructurethat integrates many aspects of providing home renal therapy. The systemand method in one embodiment integrates the training of patients toproperly use various medical devices, transferring data to a centralrepository maintained by a therapy provider, providing reports oftreatment data to clinicians, integrating with billing and orderingsystems, tracking consumables usage and delivering consumables asneeded, and servicing and maintaining the machines on a network of thesystem.

In one embodiment, a home medical device system includes a plurality ofhome medical devices including a renal therapy machine, such as, but notlimited to, a home hemodialysis (“HD”) machine, a home peritonealdialysis (“PD”) machine, a home hemofiltration (“HF”) machine, a homehemodiafiltration (“HDF”) machine, and a home continuous renalreplacement (“CRRT”) machine. While renal therapy is one focus of thepresent disclosure, the present disclosure also contemplates theintegration of any home fluid delivery therapy, such as in addition, ahome drug delivery therapy or a nutritional therapy. The machine may beat the home of the patient, or any other dwelling, such as, for example,a hotel room, vacation home, temporary shelter, nursing home, etc. Themedical device system includes a system hub coupled to the renal therapymachine through a connectivity server, a web portal configured to accessthe system hub, and an enterprise resource planning system coupled tothe system hub. The enterprise resource planning system may store adoctor's prescription for example. Renal therapy, for example, accordingto the prescription is performed by a home medical machine on a patient.

In one embodiment, the home medical device system also includes a methodfor home renal therapy training. A patient is trained on a first renaltherapy machine in a clinic. A unique patient identification (“ID”) isgenerated for that patient. A second renal therapy machine is sent tothe patient's home. The second renal therapy machine is linked to thepatient by entering the patient ID. The second renal therapy machine isthen used by the patient for home renal therapy. The second machine isat least substantially similar to the first machine so that the patientis already familiar with the machine and the corresponding therapy.

In one embodiment, the home medical device system also includes a methodfor obtaining and transferring treatment prescriptions. A doctor'sprescription for a renal or other type of therapy is retrieved. Aclinician can remotely select, based upon the doctor's prescription,supplies to send to the patient's home, such as a dialyzer. Theclinician can also remotely set settings for operating the renal therapymachine according to the prescription. The settings can be in the formof parameters or ranges that allow the patient to select a value withinthe range. Any selection is doctor approved. Nevertheless, the patienthas some input into the treatment that the home therapy machineperforms. The clinician may remotely update the settings for the renaltherapy machine. The supplies and the treatment program for the renaltherapy machine are sent to the patient and the patient performs renaltreatment at home according to the settings.

In one embodiment, the system includes a method for safely allowingnetwork or internet access. A connectivity agent resides on each renaltherapy machine. The connectivity agent is turned off before eachtreatment and is turned on after the renal therapy machine is finishedwith the treatment. This way, the network connection cannot interrupttreatment. In one embodiment, the connectivity agent is not turned onuntil the renal therapy machine is finished disinfecting itself. Duringtreatment, the renal therapy machine generates log files that documentevents that occur during treatment. The connectivity agent sends the logfiles to a connectivity server after treatment is completed, oralternatively after disinfection. In one embodiment, before eachtreatment and before the connectivity agent is turned off, the renaltherapy machine checks whether the connectivity server has any updatesor modifications to the renal therapy machine settings.

In one embodiment, the system includes a method for upgrading firmwareon a renal therapy machine. When upgraded firmware is generated, adirector, e.g., a service director, may need to approve the upgradedfirmware. The director may for example decide that renal therapymachines in only certain regions should receive the upgraded firmware.Authority is given by the director to local service personnel. Theservice personnel work closely with their patients and their associatedrenal therapy machines and are allowed leeway for when to actuallyupgrade the firmware on the service person's approved renal therapymachines. In one embodiment, the system includes a method for securelyadding users and submitting new device programs. When certain changesare made to settings within the system, the system may requireadditional authentication information from the user. Or, the system mayrequire another user to agree with certain changes before the changesare implemented.

The present systems and methods also manage and keep track ofconsumables at a patient's home. In one embodiment, a large number ofpatient prescriptions for a given patient can be supported. The durationof use of the machine and components thereof are also tracked. Machineperformance is also tracked. When a machine component expires or showssigns of disrepair, a local service person assigned to monitor theparticular machine notices same and schedules a service call.

The present systems and methods store large amounts of treatment andassociated data. In one embodiment, sensitive patient data is stored ina Health Insurance Portability and Accountability Act (“HIPAA”)compliant database, billing and ordering information is stored in abilling and ordering database, and customer management information isstored in a customer relationship database.

While dialysis, such as hemodialysis, is one type of therapy that can beimplemented at home via the systems and method of the presentdisclosure, other blood therapies, such as hemofiltration,hemodiafiltration, continuous renal replacement therapy (“CRRT”) mayalternatively or additionally be implemented at the patient's home.Other dialysis treatments, such as peritoneal dialysis, mayalternatively or additionally be implemented at the patient's home.Other home-related therapies, such as nutritional supplementing ormedical delivery of a drug via one or more infusion pump mayalternatively or additionally be implemented. With any of thesetherapies, it is contemplated to train the patient initially using thesystem and method of the present disclosure at a training facility or ahospital.

Based on the foregoing and following description, it should beappreciated that it is an advantage of the present disclosure to providea high level of supervision and reporting for home renal therapy.

It is another advantage of the present disclosure to provide anefficient and timely inventory management system for home renal therapyconsumables.

It is a further advantage of the present disclosure to provide areliable maintenance and service infrastructure.

It is yet another advantage of the present disclosure to provideclinicians, doctors and nurses the ability to remotely review andmonitor treatment data and to modify and update settings of the renaltherapy machines.

It is yet a further advantage of the present disclosure to provide easyto use and secure user interfaces for specifying supplies and forspecifying settings of the renal therapy machines via the developmentand remote transfer of one or more therapy prescriptions for thepatient.

It is yet another advantage of the present disclosure to providetraining to familiarize patients with the renal therapy and to allowpatients flexibility in administering the treatment at home.

It is yet another advantage of the present disclosure to convenientlyprovide and transfer customized software for a user interface of therenal therapy machine.

It is a further advantage of the present disclosure to provide areliable verification technique for verifying that correct types andamounts of consumables are used at home with the renal therapy machines.

Moreover, it is an advantage of the present disclosure to providemultiple home medical devices all working cohesively to reliablyrecreate the in-clinic dialysis experience in the convenience of apatient's home.

Additional features and advantages are described herein and will beapparent from the following Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A is a schematic block diagram of one embodiment of a home medicaldevice system of the present disclosure.

FIG. 1B is a block diagram showing one example of a computing deviceused in the home medical device system of the present disclosure.

FIG. 2 is a flowchart of an example process of the present disclosurefor preparing a patient to use a renal therapy machine at home.

FIG. 3 is a flowchart of an example process of the present disclosurefor shipping inventory and programming a renal therapy machine basedupon an approved treatment prescription.

FIG. 4 is a flowchart of an example process of the present disclosurefor transferring data between a renal therapy machine and a connectivityserver, for example, to send a device operating program from the serverto the renal therapy machine.

FIG. 5 is a flowchart of an example process of the present disclosurefor upgrading firmware on a renal therapy machine.

FIG. 6 is a flowchart of an example process of the present disclosurefor setting and evaluating rules for notifications and presentingtreatment data in a clinician dashboard.

FIG. 7 is a flowchart of an example process of the present disclosurefor securely creating or adding users and submitting device programs.

FIG. 8 is a screen shot of an example patient site map of the presentdisclosure.

FIG. 9 is a screen shot of an example clinician site map of the presentdisclosure.

FIG. 10 is a screen shot of an example treatment prescription screen ofthe present disclosure.

FIG. 11 is a screen shot of an example treatment prescription templateof the present disclosure.

FIG. 12A is a screen shot of an example dashboard screen for a clinic ofthe present disclosure.

FIG. 12B is a screen shot of an example legend for a dashboard screen ofthe present disclosure.

FIG. 13A is a screen shot of an example patient snapshot screen of thepresent disclosure.

FIG. 13B is another screen shot of an example patient snapshot screen ofthe present disclosure.

FIG. 14A is a screen shot of an example treatment summary screen of thepresent disclosure.

FIG. 14B is another screen shot of an example treatment summary screenof the present disclosure.

FIG. 15A is a screen shot of an example device settings screen of thepresent disclosure.

FIG. 15B is a screen shot of an example patient settings screen of thepresent disclosure.

FIG. 15C is a screen shot of an example system settings screen of thepresent disclosure.

FIG. 16A is a screen shot of an example device program screen of thepresent disclosure.

FIG. 16B is another screen shot of an example device program screen ofthe present disclosure.

FIG. 16C is a further screen shot of an example device program screen ofthe present disclosure.

FIG. 16D is yet another screen shot of an example device program screenof the present disclosure.

FIG. 16E is yet a further screen shot of an example device programscreen of the present disclosure.

FIG. 16F is still another screen shot of an example device programscreen of the present disclosure.

FIG. 16G is still a further screen shot of an example device programscreen of the present disclosure.

FIG. 17A is a screen shot of an example device setting templates screenof the present disclosure.

FIG. 17B is a screen shot of an example device program template screenof the present disclosure.

FIG. 17C is a screen shot of an example flag rules screen of the presentdisclosure.

FIG. 17D is another screen shot of an example flag rules screen of thepresent disclosure.

FIG. 17E is a further screen shot of an example flag rules screen of thepresent disclosure.

FIG. 18A is a screen shot of a users screen of the present disclosure.

FIG. 18B is another screen shot of a users screen of the presentdisclosure.

FIG. 18C is a further screen shot of a users screen of the presentdisclosure.

FIG. 18D is yet another screen shot of a users screen of the presentdisclosure.

FIG. 18E is yet a further screen shot of a users screen of the presentdisclosure.

FIG. 19 is a screen shot of an example patient treatment history reportof the present disclosure.

FIG. 20 is a screen shot of an example patient usage report of thepresent disclosure.

FIG. 21 is a screen shot of an example dialyzer status report of thepresent disclosure.

FIG. 22 is a screen shot of an example clinic usage report of thepresent disclosure.

FIG. 23 is a screen shot of an example clinic vitals report of thepresent disclosure.

FIG. 24 is a screen shot of an example clinic treatment history reportof the present disclosure.

FIG. 25 is a screen shot of an example device program history report ofthe present disclosure.

FIG. 26 is a screen shot of an example operator interventions report ofthe present disclosure.

FIG. 27 is a screen shot of an example treatment snapshot export reportof the present disclosure.

FIG. 28 is a screen shot of an example daily complaints report of thepresent disclosure.

FIG. 29 is a screen shot of an example complaints reconciliation reportof the present disclosure.

FIG. 30A is a screen shot of an example dashboard screen for a clinic ofthe present disclosure.

FIG. 30B is a screen shot of another example dashboard screen for aclinic of the present disclosure.

FIG. 30C is a screen shot of an example legend for a dashboard screen ofthe present disclosure.

FIG. 31A is a screen shot of an example patient snapshot screen of thepresent disclosure.

FIG. 31B is a screen shot of another example patient snapshot screen ofthe present disclosure.

FIG. 32A is a screen shot of an example treatment summary screen of thepresent disclosure.

FIG. 32B is a screen shot of a further example treatment summary screenof the present disclosure.

FIG. 33 is a screen shot of an example device settings screen of thepresent disclosure.

FIG. 34A is a screen shot of an example device program screen of thepresent disclosure.

FIG. 34B is a screen shot of another example device program screen ofthe present disclosure.

FIG. 34C is a screen shot of a further example device program screen ofthe present disclosure.

FIG. 34D is a screen shot of yet another example device program screenof the present disclosure.

FIG. 34E is a screen shot of yet a further example device program screenof the present disclosure.

FIG. 34F is a screen shot of still another example device program screenof the present disclosure.

FIG. 34G is a screen shot of yet another example device program screenof the present disclosure.

FIG. 34H is a screen shot of an example device program confirmationscreen of the present disclosure.

FIG. 35A is a screen shot of an example patient settings screen of thepresent disclosure.

FIG. 35B is a screen shot of an example patient settings confirmationscreen of the present disclosure.

FIG. 36A is a screen shot of an example system settings screen of thepresent disclosure.

FIG. 36B is a screen shot of another example system settings screen ofthe present disclosure.

FIG. 36C is a screen shot of a further example system settings screen ofthe present disclosure.

FIG. 36D is a screen shot of yet another example system settings screenof the present disclosure.

FIG. 37A is a screen shot of an example device setting templates screenof the present disclosure.

FIG. 37B is a screen shot of an example device program template screenof the present disclosure.

FIG. 38A is a screen shot of an example flag rules screen of the presentdisclosure.

FIG. 38B is a screen shot of another example flag rules screen of thepresent disclosure.

FIG. 39A is an example screen shot of a patient list screen of thepresent disclosure.

FIG. 39B is a screen shot of an example legend for a patient list screenof the present disclosure.

FIG. 39C is a screen shot of another example patient list screen of thepresent disclosure.

FIG. 40A is an example screen shot of a patient information screen ofthe present disclosure.

FIG. 40B is a screen shot of another example patient information screenof the present disclosure.

FIG. 40C is a screen shot of a further example patient informationscreen of the present disclosure.

FIG. 41A is a screen shot of an example add patient screen of thepresent disclosure.

FIG. 41B is a screen shot of another example add patient screen of thepresent disclosure.

FIG. 41C is a screen shot of a further example add patient screen of thepresent disclosure.

FIG. 42A is a screen shot of an example therapy information screen ofthe present disclosure.

FIG. 42B is a screen shot of an example therapy information screen ofthe present disclosure.

FIG. 42C is an example screen shot of a further example therapyinformation screen of the present disclosure.

FIG. 43A is a screen shot of an example patient order screen of thepresent disclosure.

FIG. 43B is a screen shot of another example patient order screen of thepresent disclosure.

FIG. 43C is a screen shot of a further example patient order screen ofthe present disclosure.

FIG. 43D is a screen shot of yet another example patient order screen ofthe present disclosure.

FIG. 44 is a screen shot of an example patient dashboard screen for apatient of the present disclosure.

FIG. 45A is a screen shot of an example patient order screen for apatient of the present disclosure.

FIG. 45B is a screen shot of another example patient order screen for apatient of the present disclosure.

FIG. 45C is a screen shot of a further example patient order screen fora patient of the present disclosure.

FIG. 45D is a screen shot of yet another example patient order screenfor a patient of the present disclosure.

FIG. 45E is a screen shot of yet a further example patient order screenfor a patient of the present disclosure.

FIG. 45F is a screen shot of still another example patient order screenfor a patient of the present disclosure.

FIG. 45G is a screen shot of still a further example patient orderscreen for a patient of the present disclosure.

FIG. 46A is a screen shot of an example confirmation screen of thepresent disclosure.

FIG. 46B is a screen shot of another example confirmation screen of thepresent disclosure.

DETAILED DESCRIPTION

Referring now to the drawings and in particular to FIG. 1A, a homemedical device system 110 includes, among many other features discussedbelow, a renal therapy machine 100, a wireless scale 106, a wirelesstablet user interface 122, a blood pressure monitor 104, a watertreatment device 108 and a modem 102. The components listed are ingeneral the components located within the patient's home, as indicatedby the dotted lines in FIG. 1A. Machine 100 may be located at thepatient's home or any other dwelling, such as for example, a hotel room,vacation room, temporary shelter, nursing home, a vacation home or acorporate apartment provided by an employer of the patient. If renaltherapy machine 100 is a home hemodialysis machine, one suitable machineis set forth in U.S. Patent Publication No. 2009/0101549, entitled,“Modular Assembly For A Hemodialysis System”, filed Aug. 27, 2008, theentire contents of which are incorporated herein by reference and reliedupon. One suitable water treatment device 108 is set forth in U.S.Patent Publication No. 2011/0197971, entitled, “Water PurificationSystem And Method”, filed Apr. 25, 2011, the entire contents of whichare incorporated herein by reference and relied upon.

The renal therapy machine 100 is in general the nexus or hub between thecomponents at the patient's home and can communicate with devices 104,106, 108 and 122. The scale 106, blood pressure monitor 104, tablet 122,and water treatment device 108 communicate in one embodiment only withrenal therapy machine 100. Any of components 104, 106, 108 and 122 maycommunicate wirelessly with renal therapy machine 100 or be in wiredcommunication with same. Wireless communication may be via Bluetooth™ orWiFi™ wireless communication technology. Alternatively, any ofcomponents 104, 106, 108 and 122 can communicate with renal therapymachine 100 via wired communication.

The blood pressure monitor 104 may be provided with a blood pressuremodule that plugs into the renal therapy machine 100. For example, theblood pressure module of monitor 104 may include a printed circuit boardcontroller that plugs into a controller bus of machine 100. The moduleof monitor 104 communicates thereafter via data bus communication with aprimary control processor (“ACPU”) 112. The blood pressure module ofmonitor 104 is connected pneumatically to a blood pressure cuff thatextends outside of machine 100. The patient then presses a button onuser interface 122, e.g., a wireless tablet user interface, topressurize the cuff. The cuff may be pressurized via pneumatics locatedwithin therapy machine 100. Or, the module of monitor 104 may beprovided with its own small pneumatic air pump that inflates the cuff.The patient's blood pressure is logged by ACPU 112 and may be read outto the patient on one or both of the cuff of monitor 104 or userinterface 122. One suitable module for blood pressure monitor 104 isprovided by Microlife, model 3AC1-PC, which is embedded into renaltherapy machine so only the tube and the cuff of blood pressure monitor104 are visible to a patient. Again, monitor and cuff 104 may bewireless alternatively.

The patient weighs himself or herself via scale 106. The weight is thensent to ACPU 112, e.g., via wired or wireless communication. ACPU 112uses the weight in one embodiment to calculate how much ultrafiltrationor ultrafiltrate (“UF”) is removed from the patient. One suitablewireless weight scale 106 is provided by LifeSource (A&D)®, modelUC-321PBT. In a further alternative embodiment, the patient weighshimself or herself and enters that value into system 110, e.g., viatablet user interface 122.

The water treatment device 108 connects to the renal therapy machine 100through an Ethernet cable in one embodiment. The water treatment device108 is normally powered. The renal therapy machine 100 can request wateras needed from water treatment device 108. Water treatment device 108 isconfigured to supply, on an online basis, any amount of water thatmachine 100 needs. Renal therapy machine 100 controls and receives datafrom the water treatment device 108. In one embodiment, the tablet 122does not control water treatment device 108. Instead, water treatmentdevice 108 is a slave to the programmed ACPU 112. The water treatmentdevice 108 can inform the renal therapy machine 100 of its status, suchas an alarm situation, and send any other pertinent data to ACPU 112.Renal therapy machine 100 stores and acts upon the data, e.g., decideswhether to raise an alarm. Water treatment device 108 in an embodimentinclude a small user interface and display.

In one embodiment, the renal therapy machine 100 performs hemodialysison a patient at the patient's home and then reports the results of thattreatment to clinicians, doctors and nurses who are responsible formanaging the health and well-being of that patient. To generate reports,renal therapy machine 100 can use a Linux™ operating system operated byACPU 112. Renal therapy machine 100 writes log files using the operatingsystem. The log files document pertinent parameters and activities ofthe renal therapy machine 100 and the patient over the course oftreatment. The log files may be any one or more of Extensible MarkupLanguage (“XML”), comma-separated values (“CSV”) or text files. The logfiles are placed into a file server box of the software of renal therapymachine 100. The treatment may take several hours and have many stepsand sub-steps, each yielding logged data. As illustrated in FIG. 1A, inone embodiment, tablet 122 includes a camera 136. The tablet 122 may usecamera 136 to take photographs or videos of the patient as the renaltherapy machine 100 performs therapy. For example, a patient may be ableto photograph inflammation of the skin caused by insertion of a needleinto the patient's vein or artery. The log files may include photos orvideos recorded with camera 136.

In one embodiment, ACPU 112 and user interface 122 of renal therapymachine 100 walk the patient through the entire treatment process andinstruct the patient on a step-by-step basis to perform the treatment.The user interface screens are standardized but are populated with datathat machine 100 receives from clinicians (as described in detailbelow). The instructions are according to a doctor's prescription andprovide parameters by which machine 100 operates, such as the bloodflowrate, dialysate flowrate and ultrafiltrate volume. Renal therapymachine 100 performs a treatment and records that the treatment has beenperformed according to the parameters. Errors, alerts, alarm conditionsand whether or not treatment steps have been successfully performed arerecorded. The renal therapy machine 100 records this information bycreating the log files that document each treatment.

The treatment may occur over several hours. After the treatment, therenal therapy machine 100 instructs the patient to disconnect from themachine. The renal therapy machine 100 then enters into a disinfectionmode and prepares itself for the next treatment, which may take placethe next day or a few days later. The water treatment device 108, whichprovides water to the renal therapy machine 100 as needed, also recordsand maintains its own log files that document the actions taken by thewater treatment device 108 and any alarm or alert events that occur overa treatment. The water treatment device 108 in one embodiment does notwrite directly to the log files of renal therapy machine 100 log files.Renal therapy machine 100 may however include some data or parameterssent from water treatment device 108 that machine 100 records in its ownlog files. For example, the renal therapy machine 100 may record howmuch water treatment device 108 has made and delivered to machine 100and add that information to the machine's own log files. Data stored onwater treatment device 108 that is not sent to machine 100 may otherwisebe obtained via the Ethernet data connection to water treatment device108. For example, a service person can access the additional data via alaptop connection to water treatment device 108 via the Ethernetconnection.

In one embodiment, the user interface 122 is a tablet that runs acustom, secure interface that only allows access to the renal therapymachine 100. In one implementation, tablet 122 operates wirelessly.Tablet 122 here can plug into the renal therapy machine 100 initiallyfor pairing the tablet 122 with the renal therapy machine 100 and forperforming software (e.g., firmware) upgrades. Tablet 122 may also pluginto the renal therapy machine 100 to power or charge the tablet 122.Connectivity between tablet 122 and renal therapy machine 100 may be viaa serial data connection, over a universal serial bus (“USB”)connection, parallel connection or via another suitable data transferinterface. Once the tablet 122 is paired to the renal therapy machine100, the tablet 122 communicates wirelessly (e.g., using Bluetooth™ orWiFi™) with the renal therapy machine 100.

In one embodiment, renal therapy machine 100 is Bluetooth™ or WiFi™enabled via an associated chip located with the other electronics ofmachine 100, e.g., with ACPU 112 discussed below. If it is found howeverthat having a Bluetooth™ or WiFi™ chip on a renal therapy machine 100circuit board (inside the renal therapy machine 100) causeselectromagnetic interference with the circuit board, tablet 122 mayalternatively use a Bluetooth™ dongle, WiFi™ dongle or other like devicethat plugs removably into the renal therapy machine 100, e.g., over aUSB connection, which adds Bluetooth™ functionality, for example, to anon-Bluetooth™ device.

In one embodiment, tablet 122 serves as a user interface to the renaltherapy machine 100 in the sense that the user can send data to andreceive data from machine 100 via tablet 122. Data entered into the userinterface is securely sent to the renal therapy machine 100 andprocessed in ACPU 112, which actually controls the machine. In oneembodiment, all treatment data is stored in the renal therapy machine100, not the tablet 122. Storing no treatment data in the tablet 122 isadvantageous because if the tablet 122 is disconnected or lost nosensitive or important data is lost.

While user interface 122 is described below as a wireless userinterface, mainly, user interface can alternatively be tethered tomachine 100, for example, as shown and described in U.S. PatentPublication No. 2009/0114582, the entire contents of which areincorporated herein by reference and relied upon. Unless otherwisestated, however, the functional relationship between user interface 122and machine 100 remains the same.

In one embodiment, tablet 122 runs a customized version of the Android™operating system. The standard Android™ operating system displays atoolbar that always remains on the screen, even when applications arerunning on a tablet 122. The toolbar can pose a security risk for homemedical device system 110 because the toolbar may allow otherapplications on tablet 122 to access the renal therapy machine 100. Thetoolbar may also allow the user to access other applications when theuser interface of system 110 should be displayed. The customized tabletoperating system in one embodiment removes all functionality of theAndroid™ operating system, including the toolbar, and only allows theuse of the system application, which provides the user interface to therenal therapy machine 100. The tablet 122 in one embodiment can onlycommunicate with the renal therapy machine 100. Tablet 122 accordinglydoes not need its own Internet connection.

Renal therapy machine 100 in one embodiment accesses the Internet usinga separate 3G modem 102 provided as part of the home medical devicesystem 110. The 3G modem 102 may use an Internet Service Provider(“ISP”), such as Vodafone™. In one embodiment, because the patient canpotentially connect other personal devices, e.g., laptop or mobilephone, to the 3G modem 102, system 110 monitors the usage on the 3Gmodem 102 to ensure that only the renal therapy machine 100 uses 3Gmodem 102. Clinics associated with a particular patient may receiveperiodic reports containing usage information from a provider of the 3Gmodem 102. Clinicians can review the reports to determine if aparticular 3G modem 102 is accessing the Internet more often thangenerally needed to connect renal therapy machine 100 to theconnectivity server 118. The system 110 may send a signal to clinicsnotifying clinics that a 3G modem 102's Internet usage exceeds apredetermined amount. In an alternative embodiment, system 110 placessoftware restrictions on the 3G modem 102 so that no device other thanrenal therapy machine 100 can use the 3G modem 102 to connect to theInternet. That is, a patient may be able to physically connect personaldevices to the 3G modem 102, but software running on the 3G modem 102 isconfigured to only provide Internet connectivity to the renal therapymachine 100. Alternatively, the 3G modem 102 may be hardwired directlyto the renal therapy machine 100 and no other device can physicallyconnect to the 3G modem 102. In this embodiment, the renal therapymachine 100 and 3G modem 102 are permanently attached. The system 110sends a signal to the associated clinic if a patient tampers with the 3Gmodem 102 by removing the hardwired connection to renal therapy machine100 or trying to connect a personal device to the 3G modem 102.

It should be understood that even though modem 102 is described as beinga 3G modem, the modem 102 may use other available networkingtechnologies and protocols, such as 4G and technologies developed in thefuture. In one embodiment, a dedicated line is provided at eachpatient's home for connecting the renal therapy machine 100 to theconnectivity server 118 via modem 102.

Renal therapy machine 100 in one embodiment, via the Internet, uses aconnectivity service to transfer data between modem 102 and a system hub120. There are various ways in which it is contemplated to implement theconnectivity service. In one implementation, software is stored on ACPU112 that accesses the software libraries needed to use the connectivityservice. In another implementation a connectivity agent 114 developed bythe connectivity service provider is installed onto the renal therapymachine 100 and run on ACPU 112. An example connectivity serviceprovider is Axeda™. While this application is discussed primarily withconnectivity agent 114, the functionality attributed to it herein isalso applicable to the customized connectivity service alternative. Theconnectivity service provides a secure managed connection 116 betweenmedical devices and the connectivity server 118. The connectivityservice in one embodiment also maintains information about all of therenal therapy machines 100 connected to server 118 and system 110.

The connectivity agent 114 allows the renal therapy machine 100 toconnect to connectivity server 118 and transfer data to and from theconnectivity server 118. The connectivity service operating via agent114 and server 118 ensures that the connection with machine 100 issecure, ensures that the data correctly passes through its firewalls,checks whether there has been a data or system crash and checks whetherand ensures that the connectivity server 118 is communicating with thecorrect renal therapy machine 100. The renal therapy machine 100 createsthe log files and provides the log files to the connectivity agent 114.The renal therapy machine 100 works with the connectivity agent 114 totransport the log files to the connectivity server 118. To send data tothe connectivity server 118, the renal therapy machine 100 allows theconnectivity service to run remote scripts on the renal therapy machine100.

In one embodiment, renal therapy machine 100 can only connect to theconnectivity server 118 when the connectivity agent 114 is turned on.During treatment and post-treatment disinfection, while machine 100 isfunctioning, connectivity agent 114 is turned off. This prevents therenal therapy machine 100 from communicating with any entity and sendingor receiving data during treatment and disinfection or when machine 100is live or running. In an alternative embodiment, the connectivity agent114 is turned on after treatment but before post-treatment disinfection.The 3G modem 102 may or may not remain on or activated at these machinelive times, but connectivity agent 114 is off. Renal therapy machine100, however, compiles the data it has collected during treatment,encrypts that data into log files and then places the log files in adirectory on the renal therapy machine 100. In one embodiment, when therenal therapy machine 100 is idle, e.g., after treatment is complete,the ACPU 112 turns connectivity agent 114 on. Connectivity agent 114then retrieves the log files from the renal therapy machine 100 andtransfers data to the connectivity server 118 using the connectivityservice. The connectivity service routes data packets to their properdestination but in one embodiment does not modify, access, or encryptthe data. Indeed, the data may be sensitive patient-related data thatshould only be manipulated or “looked at” by authorized users.

In system 110 of FIG. 1A, the connectivity service via connectivityserver 118 can communicate data to various places via a system hub 120and a service portal 130. Connectivity server 118 allows servicepersonnel 132 a to 132 n and/or clinicians to track and retrieve variousassets across the network, such as appropriate renal therapy machines100 and 3G modem 112, and their associated information, includingmachine or modem serial numbers. The connectivity server 118 can also beused to receive and provide firmware upgrades, approved by a director ofservice personnel 134, obtained remotely via service portal 130 toauthorized renal therapy machines 100.

In one embodiment, the renal therapy machine 100 may be operated in aservice mode for service personnel to access, diagnose and troubleshootthe renal therapy machine 100 on site and/or remotely. For example, if apatient using a renal therapy machine 100 encounters a problem, thepatient may be able to call a service personnel or technician. Thepatient and/or service person may then be able to place the renaltherapy machine 100 into a service mode that allows the servicetechnician to remotely verify machine settings and functionality forvarious components of renal therapy machine 100. For example, theservice person may be able to logon onto machine 100 while treatment ispaused. Alternatively, machine 100 must be in an idle state, or evenpowered down, for the service person to be able to access the machine.Further alternatively, the machine 100 need only be disconnected fromthe patient for the service person to be able to access the machine.Once accessed, the service technician may be able to remotelyinvestigate and retrieve the log files stored on the renal therapymachine 100 to determine the cause of the error. The service person mayalso be able to toggle valves and run a heater, for example, to see if arelated sensor, e.g., pressure, conductivity or temperature sensor isoperating properly and/or if the valve or heater (for example) isoperating properly.

The connectivity server 118 communicates with much of home medicaldevice system 110 via a home medical device system hub 120. System hub120 enables data and information concerning each renal therapy machine100 on system 110 to travel back and forth via the connectivity servicebetween the machines 100 and the clients connected to server 118. In theillustrated embodiment, system hub 120 is connected to an enterpriseresource planning system 140, a service portal 130, a web portal 150, abusiness intelligence portal 160, a HIPAA compliant database 124, aproduct development team 128 and electronic medical records databases126 a to 126 n. Web portal 150 in turn enables patients and clinics 152a to 152 n treating the patients to access a publicly available websitefor system 110. Thus while machine 100 and associated instructions anddata are kept in a protected and regulated environment, the patient andpatient's clinic are free to access the website. The patient may do sousing the patient's own computer but not using tablet 122 or machine 100in one embodiment. System 110 may require that the patient or clinicenter a username and password to access a patient or clinician's accounton the website at portal 150. In this manner, the public is restrictedfrom patient-specific data that the patient can receive. Clinician datais restricted to that clinic.

The enterprise resource planning system 140 obtains and compiles datagenerated by patient and clinician website access, such as complaints,billing information and life cycle management information. Data sentfrom the system hub 120 or portal 150 to the enterprise resourceplanning system 140 may be de-identified data, meaning the patientcannot be identified from the sent data. For example, data aboutcomplaints will not be associated with a patient. Data sent to marketing162, research and development 164 and product development 128 may alsobe de-identified. Other data can be patient specific. For example,billing data over hub 120 will be associated with a patient. Or,quality/pharmacovigilance 166 data may also be associated with apatient. The enterprise resource planning system 140 is connected in theillustrated embodiment to a billing and ordering database 142. Billingand ordering database 142 contains a doctor's electronic signatureauthorizing certain supplies for carrying out patient prescriptions. Theenterprise resource planning system 140 is also connected in theillustrated embodiment to a customer relationship management (“CRM”)database 144 storing information about enterprise resource planningsystem 140.

The electronic medical records (“EMR”) databases 126 a to 126 n containelectronic information about patients. The system hub 120 can send thedata collected from the log files of machine 100 to hospital or clinicdatabases 126 a to 126 n to merge or supplement that patient's medicalrecords. Databases 126 a to 126 n contain patient-specific treatment andprescription data and therefore access to such databases is highlyrestricted.

As discussed, web portal 150 is a portal for clinicians and patients toaccess the website and system hub 120. Clinicians can use the web portal150 to update one or more device programs for the renal therapy machines100. The system hub 120 scans through the renal therapy machine 100 logfiles to display the treatment data to a clinician through the webportal 150. Clinicians can access the web portal 150 from anywhere theycan access the Internet, including their homes. A password is requiredin one embodiment. A clinician will see various web portal 150administrative screens to set up an account. In one embodiment, the webportal 150 also connects to the enterprise resource planning system 140.Clinicians may also use the web portal 150 to send questionnaires oralerts to a patient. For example, a clinician may send a questionnaireto a patient asking the patient about a recent therapy. The questionsmay be multiple choice questions or Yes/No questions that can be easilyand quickly answered by the patient. The clinician may also use webportal 150 to send reminders or alerts about an upcoming doctor's visitor the status of a shipment of supplies.

Business intelligence portal 160 collects data from the system hub 120and provides data to marketing 162, research and development 164, andquality/pharmacovigilance 166. In one embodiment, the system hub 120de-identifies data by removing any patient-specific information andsends de-identified data periodically, e.g., once a day, to the businessintelligence portal 160. Marketing 162, research and development 164,and quality/pharmacovigilance 166 can analyze the de-identified data andprovide reporting information about treatment data.

A block diagram of the electrical systems of any of the devices orsubsystems of the home medical device system (e.g., machine 100, modem102, blood pressure monitor 104, scale 106, water treatment device 108,server 118, system hub 120, user interface 122, service portal 130,enterprise resource planning system 140, web portal 150, businessintelligence portal 160) is illustrated in FIG. 1B. System 110,including any or all of devices or subsystems 100, 102, 104, 106, 108,118, 120, 122, 130, 140, 150, and 160, includes a main unit 170 whichpreferably includes one or more processors 176 electrically coupled byan address/data bus 178 to one or more memory devices 174, othercomputer circuitry 172, and one or more interface circuits 180.Processor 176 may be any suitable processor, such as a microprocessorfrom the INTEL PENTIUM® family of microprocessors. The memory 174preferably includes volatile memory and non-volatile memory. Memory 174can store a software program that interacts with the other devices inthe system 110 as described below. This program may be executed by theprocessor 176 in any suitable manner. The memory 174 may also storedigital data indicative of documents, files, programs, web pages, etc.retrieved from another computing device and/or loaded via an inputdevice 194.

The interface circuit 180 may be implemented using any suitableinterface standard, such as an Ethernet interface and/or a UniversalSerial Bus (“USB”) interface. One or more input devices 194 may beconnected to the interface circuit 180 for entering data and commandsinto the main unit 170. For example, the input device 194 may be akeyboard, mouse, touch screen, track pad, track ball, isopoint, and/or avoice recognition system. The interface circuit 180 may be connected toany type of network 182, such as an Internet, a local area network(“LAN”), a telephone network (“POTS”), and/or other networks.

One or more displays, printers, speakers, and/or other output devices192 may also be connected to the main unit 170 via the interface circuit180. The display 192 may be a cathode ray tube (“CRTs”), liquid crystaldisplays (“LCDs”), or any other type of display. The display 192generates visual displays of data generated during operation of thedevice or subsystem 100, 102, 104, 106, 108, 118, 120, 122, 130, 150,140, 160. For example, the display 192 may be used to displayinformation received from the system hub 120. The visual displays mayinclude prompts for human input, run time statistics, calculated values,data, etc.

One or more storage devices 190 may also be connected to the main unit170 via the interface circuit 180. For example, a hard drive, CD drive,DVD drive, and/or other storage devices may be connected to the mainunit 170. The storage devices 190 may store any type of suitable data.

Patient Training and Set-Up

Referring now to FIG. 2, an example process 200 for preparing a patientto use a renal therapy machine 100 at home is described. Upon startingprocess 200 at the start oval, the patient is first trained on a renaltherapy machine 100 in a clinical setting as shown at block 202. Therenal therapy machine 100 used for training is not specific to thepatient and may be used by more than one patient in the clinicalsetting. The training machine 100 at least closely mimics the machine100 that will be placed in the patient's home.

As shown at block 204, the patient is then set up as an account onsystem hub 120. As described in further detail below, a clinician, e.g.,a nurse, may generate a unique patient identifier (“ID”) using the webportal 150. In particular, the billing and ordering database 142receives new patient information from the clinician and generates theunique patient ID, which identifies that patient thereafter across theentire home medical device system 110. The unique patient ID identifiesthat patient to all clients and subsystems that are involved inproviding and supporting the home medical device system 110.

In one embodiment, a patient receives four to eight weeks of training inthe clinical setting with a training machine 100 before being allowed toperform home hemodialysis. Once the patient is properly trained, asecond renal therapy machine 100 is sent to the patient's home as shownat block 206. This second renal therapy machine 100 will be a personalmachine intended only for that patient. The personal renal therapymachine 100 is not linked on system 110 to the patient when it isshipped to the patient's home.

At the patient's home, the patient enters the unique patient IDgenerated at block 204 into the personal renal therapy machine 100 asshown at block 208. In one embodiment, a second patient identifier,e.g., a birth date or other information particular to the patient, isalso entered into the renal therapy machine 100 as shown at block 208.Entering the patient's unique ID and/or second patient identifier can beperformed via tablet 122 and links the home renal therapy machine 100 tothat patient. Based upon this entered ID and/or second patientidentifier, the home renal therapy machine 100 retrieves a patientprescription prescribed previously by a doctor and/or clinician and anyother information needed to run a treatment from system hub 120, asshown at block 210.

The home renal therapy machine 100 displays patient information to thepatient to verify that the correct patient prescription has beenretrieved, as shown at block 212. For example, the home renal therapymachine 100 may display the patient's name. The home renal therapymachine 100 prompts the patient to confirm whether the patientinformation is correct, as shown at block 214. If the patientinformation is not correct, the home renal therapy machine may displayan error message and prompt the patient to call his or her clinic, asshown at block 216. If the patient information is confirmed as beingcorrect, the home renal machine settings are set initially based uponretrieving patient prescription as shown at block 218. The home renaltherapy machine 100 now has the information needed to run a treatmentthat is prescribed specifically for the patient and his/her associatedmachine 100. Process 200 is then completed as indicated at the end oval.

In one embodiment, renal therapy machine 100 does not identify or verifythe patient each time a patient uses the renal therapy machine 100because machine 100 is used only by one patient in his or her own home.Renal therapy machine 100 may however display a message such as, “Hello,Bill Smith” each time renal therapy machine 100 is turned on and/orprompted for treatment. In the unlikely event that the wrong personattempts to use a renal therapy machine 100, the welcome message servesas a reminder or warning that the renal therapy machine 100 is onlyintended for one specific patient, e.g., Bill Smith.

Supplies and Device Program Set-Up

Medical products and drugs are shipped or delivered to a patient's homefor the renal therapy machine 100 to use during treatment. Only therapyproducts or drugs approved under a doctor's prescription can be shippedto the patient's home. In the U.S., prescriptions last one year. One ormore prescription is stored for each patient in the system hub 120. Eachrenal therapy machine 100 uses supplies and settings according to theprescription. If the patient's prescription changes or if a prescriptionis added, the patient's clinician uses web portal 150 to update therenal therapy machine 100 settings to change or add the prescription. Ifthe renal therapy machine 100 settings are updated, the system hub 120sends the updated settings to the renal therapy machine 100 via theconnectivity service as discussed previously.

Referring now to FIG. 3, process 300 illustrates an example process forshipping inventory and programming a renal therapy machine 100 basedupon a doctor's prescription for a particular patient. That is, a doctorassociated with the clinic 152 a to 152 n can also access system hub 120via web portal 150 to deliver a device program to the clinician for thepatient. Upon starting process 300 at the start oval, the clinicianretrieves an electronic prescription prescribed by a doctor using theweb portal 150 as shown at block 302. At the web portal 150, theclinician selects the dialyzer, blood tubing set, acid, bicarbonate,needles, etc. and other supplies necessary to fulfill the prescriptionrun on renal therapy machine 100. The selected dialyzer and othersupplies will be shipped to the patient's home as shown at block 304. Atthe same or different time, the clinician may remotely access the systemhub 120 through the web portal 150 to remotely program renal therapymachine 100, as shown at block 306.

To remotely program the renal therapy machine 100, the clinician selectsthe dialyzer model, treatment type and duration as shown at block 308.The clinician also sets various treatment parameters used to program therenal therapy machine 100 as shown at block 310, such as blood flowrate,dialysate flowrate, UF volume and heparin flowrate flush. The clinicianalso specifies allowed ranges for the various settings as shown at block312. That is, the patient may be allowed to pick within a range ofvalues for certain parameters under the specified device program. Inthis manner, the patient has a certain amount of control over thetreatment that is performed. Dialysate temperature, for example, may beset within a range of allowable values based upon patient preference andcomfort. The clinician further specifies whether or not the patient willhave the ability to modify the settings at all as shown at block 314. Ifthe patient is allowed to modify parameter settings, the settingvariability is within an allowed range, such that the patient picks avalue inside the range specified by the clinician at block 312. Theclinician settings and parameter ranges are discussed in further detailwith reference to FIGS. 16A to 16G as well as FIGS. 34A to 34G below.The clinician then submits the settings to the system hub 120 as shownat block 316. The system hub 120 then sends the settings to the renaltherapy machine 100 at the patient's home as shown at block 318 via theconnectivity service as discussed above. Process 300 then ends asillustrated at the end oval.

Performing Renal Therapy with an Updated Device Program

Before treatment begins, e.g., after disinfection the day before, ACPU112 of renal therapy machine 100 checks whether the connectivity servicevia agent 114 has posted an updated prescription for that particularrenal therapy machine 100. To do so, in one embodiment, the renaltherapy machine 100 and the system hub 120, through the connectivityservice, compare prescription version numbers to determine whether renaltherapy machine 100 has the most updated prescription. If not, the mostrecent prescription version is delivered to therapy machine 100.

Referring now to FIG. 4, an example process 400 for updating thepatient's device program, sending the updated device program to therenal therapy machine 100, performing therapy and transferring databetween a renal therapy machine 100 and connectivity server 118 isdescribed. The clinician at block 402 remotely updates the deviceprogram for renal therapy machine 100 using the web portal 150 asdescribed in process 300 of FIG. 3. The system hub 120 then sends theupdated device program to the connectivity server 118 as shown at block404. When the connectivity agent 114 residing at renal therapy machine100 is next turned on or enabled as shown at block 406, renal therapymachine 100 checks for an updated device program as shown at block 408.If one is present, connectivity server 118 sends the updated deviceprogram to the renal therapy machine 100 as shown at block 410.

Machine 100 prompts the patient to accept the new device program. In oneembodiment, the patient must accept the new device program to continueusing the renal therapy machine 100. In one embodiment, machine 100 willnot run an old device program if a new device program is present onmachine 100. However, the new device program will not overwrite the olddevice program until the patient accepts the new or updated deviceprogram as shown at block 412. In this manner, the patient confirms thatthe patient knows that his or her treatment has changed. Upon acceptingthe new device program, the new device program is written into thememory of therapy machine 100. In an alternative embodiment, machine 100can store multiple device programs in memory so even when a new deviceprogram is downloaded, the old device program is kept in memory. Machine100 may be able to store different types or categories of deviceprograms. Each different type of device program may provide a differenttreatment, e.g., to remove a low amount, medium amount, or large amountof ultrafiltration for dialysis. The machine 100 may be able to storeone device program in each category.

The next time the patient is about to perform treatment, theconnectivity agent 114 is turned off as shown at block 414. The renaltherapy machine 100 as shown at block 416 now runs a treatment using theupdated device program specified at block 402. Renal therapy machine 100writes treatment data produced by the new treatment to the log files asshown at block 418. Connectivity agent 114 is turned on as shown atblock 420. In one embodiment, the renal therapy machine 100 initiatesthe connection to the connectivity service. In an alternativeembodiment, the connectivity service may initiate the connection to therenal therapy machine 100. At block 422, the log files are uploaded toconnectivity server 118. Process 400 then ends as illustrated at the endoval.

Machine 100 can perform post treatment procedures, such as adisinfection procedure that cleans the machine and the disposables usedfor treatment for the next treatment. In one embodiment, system 110allows the connectivity agent to be turned on at block 420 aftertreatment but while post-treatment disinfection is taken place. Writingtreatment data at block 418 can also be done during disinfection.Alternatively, the renal therapy machine 100 waits to write data atblock 418 or turn on the connectivity agent at block 420 untildisinfection is completed and the machine 100 enters an idle mode.

In the illustrated embodiment, because the connectivity agent 114 turnsoff before treatment and does not turn on again until after treatment,system 110 provides no real-time monitoring of a treatment. Events thatoccur during a treatment, including alarms and alerts, are not reportedto the system hub 120 immediately. Such information is part of the logfiles that are sent to the system hub 120 after treatment.

In an alternative embodiment, the connectivity agent 114 may remain onduring treatment and may report information about the renal therapymachine 100 and the treatment in real-time. For example, in oneembodiment, system 110 may allow a clinician to remotely andsimultaneously view screens being viewed by the patient on userinterface 122.

Firmware Upgrades

From time to time, the software that ACPU 112 runs on renal therapymachine 100, which may also be referred to herein as firmware, may needto be upgraded. The home medical device system 110 provides a seamlessand reliable manner for upgrading firmware that integrates the productdevelopment team 128 and service personnel 132 a to 132 n.

FIG. 5 illustrates an example process 500 for upgrading firmware on therenal therapy machine 100. Upon starting process 500 at the start oval,a product development team 128 develops a firmware upgrade as shown atblock 502. At block 504, the product development team 128 uploads thefirmware upgrade to the system hub 120. The service portal 130 thenallows a service personnel director or decision-maker 134 to view andapprove the upgrade. Upon approving the upgrade, director 134 uploadsthe upgrade from system hub 120 to the connectivity server 118, as shownat block 506. In the illustrated embodiment of FIG. 1A, director 134 isseparate from the service personnel 132 a to 132 n that are responsiblefor servicing and maintaining the renal therapy machines 100 and formaintaining relationships with the patients. Service personnel director134 not only has the authority to finalize whether the upgrade is sentto the connectivity server 118, director 134 can also designate whichmachines 100 get the upgrade, if not all machines 100, and refuse theupgrade or return it to the product development team 128 for refinement.Once an upgrade is allowed to reach connectivity server 118, servicepersonnel 132 a to 132 n, or designated ones thereof, can view thefirmware upgrade through service portal 130 as illustrated at block 508.In one embodiment, the product development team 128 uploads the firmwareupgrade directly to the connectivity server 118, without going throughthe system hub 120.

As discussed above, service personnel 132 a to 132 n manage theday-to-day relationship with the patients. Service personnel 132 a to132 n are familiar with patient schedules and are in the best positionto determine when a patient should receive the firmware upgrade. Forexample, service personnel 132 a to 132 n will know the maintenance andactivity schedule for the renal therapy machines 100 they normallyservice. If the patient's machine 100 is scheduled to soon receive apart needed for the firmware upgrade, then the service personnel 132 ato 132 n can wait until the new part is installed before upgrading thefirmware (needing the new part) on the patient's renal therapy machine100.

Each service personnel 132 a to 132 n selects which of its designatedrenal therapy machines 100 should receive the firmware upgrade as shownat block 510. The next time connectivity agents 114 on the selectedrenal therapy machines 100 are turned on, as shown at block 512,connectivity server 118, waiting for the agents to be turned on, sendsthe upgrade to the selected renal therapy machines 100 as shown at block514.

In one embodiment, the selected renal therapy machines 100 may decidewhether or not to accept the upgrade, as shown at block 516. If theselected renal therapy machines 100 do not accept the upgrade, process500 ends as shown at block 516 and the end oval. If any of the selectedrenal therapy machines 100 accept the upgrade, the correspondingpatients are prompted as to whether they would like to install theupgrade, as shown at block 518. If the patients using the selected renaltherapy machines 100 do not choose to upgrade, the process 500 ends asshown at block 520 and the end oval. If the patients using the selectedrenal therapy machines 100 choose to upgrade, the upgrade is performedand the renal therapy machines 100 inform the patients that the softwarehas been upgraded as shown at block 522. Some countries require by lawthat patient approval must be obtained before upgrading a patient'sfirmware. In one embodiment, system 110 may require that only renaltherapy machines 100 in countries that require patient approval promptpatients to accept the firmware upgrade at blocks 518 and 520.

Renal therapy machines 100 may be allowed to retain the ability torevert back to a previous software version. For example, if a firmwareupgrade is corrupt, or if the firmware on a renal therapy machine 100becomes corrupt, renal therapy machine 100 in an embodiment is allowedto revert back to a previous, non-corrupt software version.Alternatively, renal therapy machine 100 cannot revert back to aprevious software version. Here, if the software is or becomescorrupted, new software is installed or renal therapy machine 100 isswapped with a new renal therapy machine 100.

The connectivity service at server 118 documents all events related tofirmware upgrades, such as which patients have received upgrades, andwhich service personnel 132 a to 132 n have been involved in theupgrades. The connectivity server 118 stores serial numbers, trackingnumbers and software versions so the various steps in the upgradeprocess are documented and so that at any given moment the currentsoftware version of each machine 100 on system 110 can be readilyobtained. At the end oval in FIG. 5, process 500 ends.

Clinician Dashboard with Rule-Evaluation

A clinician can view a list of the clinician's patients and a file foreach patient showing how treatments for the patients have transpired.The treatment files are derived from the log files in the renal therapymachine 100, including flowrates achieved, ultrafiltrate removal,ultrafiltration rates achieved, blood pressure over the course oftherapy, weight, etc. A clinician can sort the list of patients bynumerous categories, including the type of treatment they have received,e.g., hemodialysis (sub-categorized as for example short daily,nocturnal, every other day, and every other night), peritoneal dialysis(sub-categorized as continuous cycling peritoneal dialysis (“CCPD”),tidal, for example), the supervising doctor, or by the notificationsdescribed below. A clinician can also view a patient snapshot and anoverview for the week, month or other duration.

Web portal 150 provides a clinician dashboard having notifications aboutevents that occurred during treatment. In one embodiment, thenotifications include colored flags, with different colors correspondingto different notification conditions. The clinicians can choose whichevents generate the red or yellow flags that appear on the dashboard. Inone embodiment, the flag settings are clinic-specific, notpatient-specific. Thus, choosing to be notified about certain eventsapplies to all patients in the clinic or under the clinician's case. Forexample, a clinician may set a rule that a yellow flag should appear onthe dashboard if a treatment lasted less than four hours. This rulewould then apply to all patients at that clinic or under thatclinician's care. The dashboard will indicate, e.g., with yellow flags,any patients who have undergone a treatment that lasted less than fourhours.

Alternatively or additionally, there can be notifications that arepatient-specific. For example, the clinician may set for patient A thata yellow flag should appear on the dashboard if a treatment lasted lessthan four hours. The dashboard will then only apply this rule forpatient A and only generate a yellow flag if a treatment for patient Alasts less than four hours. Here, the clinician can set flags for eachpatient individually. The dashboard may show multiple yellow flags evenin this individualized embodiment, however, the flag may not be appliedto all patients of the clinic or under the clinician's care.

There may also be an indicator indicating whether the same or differentclinician has already reviewed certain one or more notifications for aparticular treatment. For example, if a clinician reviewing thedashboard sees a flag for a treatment and an indicator next to thatflag, the clinician knows that he or she or another clinician hasalready reviewed that treatment flag and its corresponding cause.

The notifications are evaluated based upon rules or settings set by aclinician. If the rules or settings are changed, the flags arere-evaluated. The dashboard reflects the most current updatednotification rules. For example, if a clinician previously set anotification rule that he should be notified if an alarm went off threetimes during treatment, but then changes that rule to be notified if analarm went off only two times, the flags are re-evaluated upon thechange. Thus here, flags may appear (indicating only two alarms) thatdid not appear before (when three alarms were needed). The dashboard isupdated based upon the updated rule. Web portal 150 enables eachclinician and each clinic to tailor the flagging of treatment conditionsto meet specific needs.

FIG. 6 describes an example process 600 for setting rules or criteria,evaluating the rules against treatment data and presenting the data on adashboard. Referring now to FIG. 6, the clinician beginning at the startoval sets the notification rules through the web portal 150 as shown atblock 602. The connectivity server 118 then sends the log files to thesystem hub 120 as shown at block 604. The system hub 120 evaluates thelog files based upon the notification rules as shown at block 606. Thesystem hub 120 then sends information from the log files and theevaluation results to the web portal 150 as shown at block 608. The webportal 150 displays a dashboard such as the dashboard shown in FIG. 12Aor the dashboard shown in FIG. 30A. The dashboard displays icons, e.g.,check marks or exclamation points (FIG. 12A, FIG. 30A), representing theresults of the evaluated notification rules as shown at block 610. Theclinician can then modify the notification rules through the web portal150 as shown at block 612 even as the clinician is viewing thedashboard. If the clinician chooses to modify the notification rules, asillustrated at block 612, the web portal 150 evaluates the modifiednotification rules in real-time and updates the dashboard as shown atblock 614. Web portal 150 may use processing at system hub 120 for thissecond evaluation, or web portal 150 may evaluate the modifiednotification rules locally. Process 600 terminates at the end oval.

Security

In one embodiment, the system 110 provides security features byrequiring verification information before certain changes can beimplemented. In one example, system 110 requires that a user, alreadyauthenticated and logged into web portal 150, must enter his or herpassword into web portal 150 again after making a certain change beforethe change is actually implemented. Here, the security feature includesa second user authentication. Or, system 110 may require that a changeis only implemented in the system if that change is approved by a seconduser. Here, the security feature is an approval entered by an authorizedapprover.

Referring now to FIG. 7, security and setup process 700 illustrates anexample security process used for creating new users and submitting newdevice or treatment programs. Upon starting process 700 at the startoval, a clinic administrator is created and confirmed with a secondaryauthentication as shown at block 702. The clinic administrator thencreates a clinic user with a device management role (explained below inconnection with FIGS. 18A to 18E) and confirms the creation of theclinic user with secondary authentication as shown at block 704.

The created clinic user can then log into system 110 and isauthenticated as shown at block 706 by entering verification informationestablished at user setup block 704. The clinic user can then createand/or update a device or treatment program as shown at block 708. Theclinic user submits the created or updated device program, confirmingthe submission with secondary authentication, as shown at block 710.

In one embodiment, system hub 120 encrypts the created or updated deviceprogram before the device program is sent to a renal therapy machine100. The renal therapy machine 100 downloads the encrypted deviceprogram from system hub 120 via connectivity server 118 and verifiespatient identification, e.g., patient date of birth, and/or programsettings as shown at block 712. Renal therapy machine 100 may verify theinformation by matching data tagged to the device program with like datastored in the memory of renal therapy machine 100. The patient thenconfirms or accepts the device program settings as shown at block 714.The process then ends as shown by the end oval for security and setupprocess 700.

In one embodiment, system 110 may implement various rules to enhancesecurity. For example, system hub 120 and/or connectivity server 118 maykeep a record of internet protocol (“IP”) addresses of all renal therapymachines 100 linked to system 110. If a renal therapy machine 100 islocated at a different IP address than the IP address normallyassociated with that renal therapy machine 100, system 110 may require asecond user, e.g., a second approver, to approve the submittal of a newdevice or treatment program to renal therapy machine 100.

Other events may also require approval from secondary sources. Forexample, if a clinic administrator tries to create a clinic user with adevice management role (FIGS. 18A to 18E), system 110 may requiresecondary approval by a designated person. Or, if a clinic user attemptsto create and/or update a device program, a secondary approval may berequired by a designated person. In a further example, anytime a deviceprogram is created or updated, the clinic administrator or a persondesignated by the clinic administrator may receive an email informingthat the clinic administrator/person about the new device program orupdate.

System 110 may also monitor and track the total number of changes beingmade to the different device programs and settings for the various renaltherapy machines. System 110 may expect a certain number of changes in agiven timeframe. If the number of changes to device program settingsexceeds the expected number of changes by a threshold amount, system 110may conclude that a security breach has occurred and shut itself down.The expected number may be set for a particular clinic, for the patientswithin the clinic, or for both.

Web Portal

Clinicians and patients can access information about the home medicaldevice system 110 via the web portal 150, which links to the rest ofsystem 110 via system hub 120. FIG. 8 illustrates an example patientsite map 800 on a patient's display device 192 that describes thevarious pages that are accessible to a patient from the web portal 150.The patient arrives at landing page 802 of site map 800 and is promptedto login at login page 804. If the login fails, a login failure page 806is displayed after which the patient can try to log in again. If thelogin fails several times, for example three times, system 110 providesa locked account page 808. If the patient has never logged in before,system 110 prompts the patient to create an account and password at page810 and accept terms and conditions at page 812. Once the patient hassuccessfully logged into system 110, system 110 displays patientdashboard 814. From dashboard 814, the patient can view his or herdevice program at screen 816 the patient's at-home inventory at screen818. Prescription screen 816 shows the treatment (or treatment optionsif multiple prescriptions are available) that machine 100 currentlyperforms for the patient. Inventory screen 818 shows the supplies thatthe patient should currently have at home. The patient may updateinventory screen 818 with information not available to system 110, forexample, subtract stock that has been damaged or lost from the patient'sat-home inventory. System 110 may log that the patient has made such anadjustment.

Clinicians also use the web portal 150 for information about the homemedical device system 110. Clinicians generally have access to moreinformation than do individual patients. In one embodiment, a cliniciancan view information about each of his or her patients through webportal 150. In one embodiment, the web portal 150 is “clinic-centric,”meaning clinicians that belong to one clinic cannot see informationabout patients or clinicians from other clinics. Nurses and cliniciansmay be associated with clinics and thus can view all patients for agiven clinic. Doctors, however, may be associated with patients, notclinics, and thus system 110 may not allow a doctor to see all thepatients associated with a clinic. A web portal administrator, usually aclinician or nurse for a particular clinic, specifies which patients adoctor can see.

FIG. 9 illustrates an example clinician site map 900 displayed on aclinician's display device 192. Clinician site map 900 includes manymore pages that are accessible to the clinician than does patient sitemap 800 for the patient. The clinician arrives at a landing page 902 andis prompted to log in. If there is a login failure, screen 904 isdisplayed. System 110 provides locked account screen 906 after severalfailed attempts. First time users are prompted to create a login andpassword at screen 908 and accept terms and conditions at screen 910.System 110 also provides help at screens 912 and 914 if the clinicianforgets or misplaces his or her login email address or password.

Once logged in, the clinician can view a dashboard 916, which allows forpatient-specific reports to be viewed. The patient-specific reports areshown on a treatment summary screen 918 and a patient snapshot screen920. From the dashboard, system 110 also allows the clinician to settreatment parameters at patient management screens 922. The patientmanagement screens 922 include screens for administrative tasks relatedto the patient such as obtaining patient information, searching forpatients, and deactivating users. The patient management screens 922include a physician therapy approval screen (not included in thefigures), therapy prescription screen (FIG. 10), device program screen(FIGS. 16A to 16G), a patient settings screen (FIGS. 15B, 35A and 35B),and a system settings screen (FIGS. 15C and 36A to 36D). The cliniciancan also access from the dashboard a clinic management module 924. Theclinician can also access account settings (not shown), access reports926 or a reports view 928.

FIG. 10 illustrates an example of a therapy prescription screen 1000displayed on a clinician's display device 192, which may be referred toherein as a supply order management screen. The upper left corner oftherapy prescription or supply order management screen 1000 providesmajor category selections for the clinicians within web portal 150.Links to each of the major categories include Patient Information,Therapy Prescription, Device Prescription, Patient Settings and SystemSettings. Device Prescription is referred to herein alternatively andinterchangeably as Device Program. Current screen 1000 is a therapyprescription screen, so “Therapy Prescription” is highlighted on thelist. To move to any other major category from screen 1000, theclinician selects one of the other links.

Therapy prescription screen 1000 allows the clinician to select theproducts and supplies that are to be delivered to a patient fortreatment. The clinician enters into screen 100 the number of treatmentsper week 1004, whether the prescription expires 1006 and the duration ofthe treatment 1008. Screen 1000 also allows the clinician to run asearch for products and accessories 1010, which then presents a list ofthe various products that the clinician searched for 1012. From thevarious products listed 1012, the clinician, according to the doctor'sprescription, selects which products 1014 to send to the patient. Thesupplies selected at screen 1000 are then delivered to the patient'sresidence. Again, the therapy prescription screen 1000 is manipulatedaccording to a doctor's prescription, which is stored in the billing andordering database 142 linked to enterprise resource planning system 140.In other words, the clinician can only order products that conform orare in accordance with a doctor's prescription.

System 110 enables the clinician to apply a template at selection 1002.The templates are created for different kinds of prescriptions, so thatselecting a specific prescription from the scroll-down menu at templateselection 1002 specifies a list of products and amounts for theclinician without having to check off or select each individual field1014. Selecting a template allows the clinician to choose from apreexisting set of products, thereby allowing the clinician to quicklyplace an order for an initial stock of supplies. The templates areextremely convenient because many patients use standard prescriptionsneeding the same supplies.

FIG. 11 illustrates an example therapy prescription template screen 1100displayed on a clinician's display device 192, which allows a clinicianto create a therapy prescription template. The clinician can enter atemplate name at box 1102, the number of treatments per week atdrop-down menu 1104, whether or not the prescription expires at checkbox 1106, an expiration date at drop-down menu 1108 and the treatmentduration at drop-down menu 1100. The clinician can then also enter aproduct search 1112 and list and select various different products thatthe clinician can ship to a patient. All of these selections are thensaved for future use and applied when the particular template isselected in field 1002 in the therapy prescription screen illustrated inFIG. 10.

Clinician Dashboard

FIG. 12A illustrates an example dashboard screen 1200 for a clinicdisplayed on a clinician's display device 192. Dashboard screen 1200 isin one implementation the first screen a clinician sees upon logginginto the web portal 150. Dashboard screen 1200 provides an overview ofinformation about the patients handled by that clinic. It should beappreciated that information in the dashboard screen is not a clinicalassessment of the patient's health or condition and does not providemedical advice, but instead provides an overview of information aboutpatients to a clinician. The patients are listed by name as shown atcolumn 1202. Dashboard 1200 may enable the clinician to apply filters asillustrated by drop down menu 1212. For example, the clinician in theillustrated embodiment can filter information in the dashboard bypatient type (not shown), by physician at drop-down menu 1212, or by thestatus of a patient (not shown). The clinician can also filterinformation in the dashboard to only show treatments for which there hasbeen no communication using checkbox 1214, or to only show treatmentsfor which a flag has been generated using checkbox 1216. The filtersallow the clinician to hone in on particular, desired information.

Various icons 1204, 1206 and 1208 indicate information about a treatmentperformed by that patient on a specific date. Icons 1204, 1206 and 1208may indicate different types of events. For example, icon 1204 may beused to indicate that a treatment has been performed successfully. Icon1206 may be used to notify the clinician about events that are notcritical and do not need immediate action, but need to be closelymonitored in the future. Icon 1208 for example may be used to notify theclinician of events that need immediate action.

A user is able to access a legend using link 1218. When a user selectslink 1218, a popup window or new screen 1250 appears. FIG. 12Billustrates an example legend screen 1250 displayed on a clinician'sdisplay device 192 that explains the various icons that can appear ondashboard screen 1200. Icon 1204 indicates that the treatment went “Ok.”Icon 1208 indicates a high priority flag. Icon 1206 indicates a flag ofnormal priority. Icon 1210 indicates that there has been nocommunication with the renal therapy machine 100 associated with thatpatient for a specific treatment.

Referring again to FIG. 12A, the dashboard screen 1200 may also includenavigational tabs to allow the clinician to access various portions ofthe web portal. For example, navigational tabs include a dashboard tab1220, a reports tab 1221, a templates tab 1222 and a users tab 1223. Aclinician can access different portions of the web portal 150 byselecting an associated navigational tab. The navigational tabs appearon multiple screens at all times in one example embodiment.

In one example embodiment, selecting a navigational tab such as tab 1220displays more navigational options. FIG. 13A illustrates an examplepatient snapshot screen 1300 displayed on a clinician's display device192 that can be launched from the dashboard screen 1200. As indicated inFIG. 13A, selecting dashboard tab 1220 displays navigational optionswithin the dashboard tab, such as a view dashboard link 1302, a viewpatient snapshot link 1304 and a view device settings link 1306. Thepatient snapshot screen 1300 provides detailed information to theclinician about an individual patient. The snapshot screen 1300 providesinformation such as the blood pressure 1308, heart rate 1310, and the UFvolume removed 1312.

The clinician may also be able to filter specific treatment data, forexample, using drop-down menu 1318. The clinician can specify whichaspect of the treatment data to view in the patient snapshot screen1300. In the illustrated embodiment, the clinician has selected patientvolumes. The clinician can also filter information by selecting a timeframe using drop-down menu 1320. In the illustrated embodiment, theclinician has selected to view treatment data over a timeframe of sevendays. Selecting seven days using drop-down menu 1320 results in thecalendar display 1322, which illustrates seven days of data for aspecific patient. A link to a legend 1324 is again provided on patientsnapshot screen 1300, which displays the same icons and explanations forthe icons as described above in FIG. 12B.

FIG. 13B illustrates additional information that may be displayed on thepatient snapshot screen 1300 displayed on a clinician's display device192. Patient snapshot screen 1300 for example displays anultrafiltration rate per kilogram 1314 and the patient's weight 1316.

FIG. 14A illustrates an example treatment summary screen 1400 displayedon a clinician's display device 192 that provides granulated detailsabout a particular treatment performed on a patient. Treatment summaryscreen 1400 can be launched by selecting one of the dates in thecalendar 1322. In the illustrated embodiment, the user has selected Jul.31, 2010. FIG. 14A shows information about the treatment for Jul. 31,2010, as indicated at chart 1402.

From treatment summary screen 1400, a clinician can see a description ofthe flag symbols at chart 1401. The clinician can also see the date,start time and total dialysis time at chart 1402, the prescribed deviceprogram at chart 1404 and overall treatment summary log in table formatshowing exact times for various treatment events at chart 1406. Thescreen 1400, displayed on a clinician's display device 192, is continuedon FIG. 14B. As shown in FIG. 14B, a clinician can see fluid managementparticulars at chart 1408, information about the treatment dose at chart1410, heparin particulars at chart 1412, dialyzer extended use data atchart 1414, blood pressure at chart 1416, pulse particulars at chart1418, pretreatment samples taken for comparison purposes at chart 1420and details about the prescribed device program at chart 1422. Theclinician can also see the device ID of the renal therapy machine 100and the software version of the renal therapy machine 100 as well as thewater treatment device 108 at chart 1424.

FIG. 15A illustrates an example device settings screen 1500 displayed ona clinician's display device 192, which can be launched from thedashboard screen 1200. The device settings screen 1500 displays relevantconsolidated information about the various device programs being used bya patient, patient settings and system settings and also provides aconsolidated location or screen for clinicians to be able to accessvarious aspects of the patient care. From the device settings screen1500, a clinician may be able to access information about deviceprograms 1502, patient settings 1504 or system settings 1506. Underdevice programs 1502, a clinician can view all of the different deviceprograms stored for that patient. For example, in the illustratedembodiment of FIG. 15A, the patient is using three different deviceprograms: short daily 1508, nocturnal 1510 and a third program titled“device program 3” 1512. The clinician may be able to create a newdevice program for that patient using link 1514. The clinician can viewor edit device programs 1502, patient settings 1504 or system settings1506 using the links in the action column 1516. The device settingsscreen also displays the last person to modify any of the deviceprograms, patient settings or system settings using the modified bycolumn 1518. The date of the modification is also shown using themodified on column 1520.

A clinician may be able to change certain settings for renal therapyusing a patient settings screen 1530 displayed on a clinician's displaydevice 192 illustrated in FIG. 15B. The patient settings screen 1530 canbe obtained by selecting view or edit under the patient settings section1504 on FIG. 15A. Changes made in the patient settings screen 1530modify how the next treatment is performed but are not immediatelyreported to the system hub 120. Instead, those changes are communicatedto the system hub 120 after the next treatment when the log files aresent to the system hub 120. Patient settings in general involve settingsthat affect how treatment is displayed to the patient and thus do notrequire a doctor's approval.

In the patient settings screen 1530 displayed on a clinician's displaydevice 192 of FIG. 15B, the clinician can apply a clinic template 1532,which like before enables the clinician to quickly and easily specifyand populate a group of preselected settings. On patient settings screen1530, the clinician can specify a treatment data interval at entry 1534,a blood sample prompt at drop-down menu 1536, a pulse prompt atdrop-down menu 1538, a standing blood pressure prompt at drop-down menu1540, a sitting blood pressure prompt at drop-down menu 1542, adialysate chemical sample prompt at drop-down menu 1544, a dialysatemicro sample prompt at drop-down menu 1546, a water composition sampleprompt at drop-down menu 1548, and a water micro sample prompt atdrop-down menu 1550. The drop-down menus specify frequency settings forthe prompts, e.g., how often does machine 100 prompt the patient for thelisted information. The clinician can use the cancel button 1554 andsubmit button 1552 to respectively cancel or submit the patientsettings. In one embodiment, a patient may be able to access the patientsettings screen 1530 to modify various settings for the renal treatment.

FIG. 15C illustrates an example screen shot of a system settings screen1570 displayed on a clinician's display device 192. The system settingsscreen 1570 allows a clinician to specify various settings related tothe operation of the system. The clinician can apply a clinic template1572, which like before enables the clinician to quickly and easilyspecify and populate a group of preselected settings. The systemsettings screen 1570 also allows a clinician to select the language typeas shown by drop-down menu 1574, specify the time format with drop-downmenu 1576, specify the date format with drop-down menu 1578, specify thenumber format with drop-down menu 1580 and specify the units for weightwith drop-down menu 1582.

The system settings screen 1570 also allows the clinician to specify aclinician password 1584. The clinician password is required thereafterfor any changes that are to be made to the renal therapy machine 100from the patient's home. For example, if a patient at his or her homewishes to modify any of the settings for the renal therapy machine 100,the patient must either be given the clinician password 1584, or aclinician who knows the clinician password 1584 must be present at thepatient's home to enter in the clinician password 1584 at the renaltherapy machine 100. The clinician password thus provides a layer ofsecurity to ensure that only authorized users are able to changesettings for a renal therapy machine 100 from the patient's home.

The system settings screen 1570 (for online hemodialysis for example)also allows a clinician to specify an acid configuration 1586 (e.g.,whether the acid is in a jug), the water system filter packconfiguration 1588, the water system reject valve setting 1590 and ahome device setting 1592. Different therapies will have different systemsettings, e.g., dialysate dextrose level for peritoneal dialysis. In oneembodiment, many of the screens and options available though web portal150 are coded to match the screens and options that appear on the renaltherapy machine 100. For example, a home device setting accessed througha renal therapy machine 100 allows a user to disable the renal therapymachine 100. Home device setting 1592, accessed through FIG. 15C, allowsa clinician to remotely turn a machine off completely. The clinician cansubmit these settings using submit button 1594 or cancel any changes tosettings by using cancel button 1596.

Device Program

FIGS. 16A to 16G illustrate an example device program screen 1600displayed on a clinician's display device 192, which allows cliniciansto set values for parameters that control how the renal therapy machine100 will perform renal treatment at the patient's home. In FIGS. 16A to16G, various fields or parameters are specified by the clinician. Thefields or parameters are the product of a doctor's prescription for thepatient. The fields or parameters as illustrated below may allow for thepatient to select a value from a range of values for one or moreparameters.

As with the therapy prescription screen, the device program screens 16Ato 16G also provide an option for the clinician to apply templates atscroll-down menu 1602. The templates are again convenient becausetemplates allow the clinicians to enter preselected values for multipleparameters at once by selecting a template. For example, the clinicianmay have many patients that each require the same treatment duration,blood flowrate and heparin dose. The clinician may save the multi-usevalues under a template, giving the template a recognizable name. Whenthe clinician wants to apply these settings to renal therapy machines100 for multiple patients, the clinician can select a template insteadof having to specify each field on device program screen 1600. Thus whencreating or modifying a device program, the template pre-populates thefields with values. From there, the clinician can change the populatedfields. If only a few fields are changed, the template has saved theclinician time and effort. The templates simplify settings for renaltherapy, but the settings are nonetheless based upon a doctor'sprescription. The templates can involve any one or more or all of thetreatment device settings discussed below. The templates for the deviceprogram screens 16A to 16G are further described in FIGS. 17A and 17B.

The device program screen 1600 contains various tabs such as a generaltab 1604 (FIG. 16A), a blood flow tab 1606 (FIG. 16B), a dialysate tab1608 (FIG. 16C), a fluid management tab 1610 (FIG. 16D), a heparin tab1612 (FIG. 16E), a backflush option tab 1614 (FIG. 16F) and another tablabeled “Other” 1616 (FIG. 16G).

Horizontal bar 1618 explains the various columns listed in each of thevarious tabs 1604 to 1616. The horizontal bar 1618 lists the same itemson tabs 1604 to 1616 and indicates that a clinician can set values, seta patient settable range, and also specify whether those values arepatient editable. Treatment features that are marked as not beingpatient editable in horizontal bar 1618 cannot be changed by a patient.For example, a clinician may be able to specify that a category or aportion thereof is not editable by a patient so that a patient would notbe able to change any settings for those values. Or, the clinician canspecify, using buttons 1619, that a patient may edit a certain value. Incertain instances, the clinician may also allow a patient theflexibility to edit values within a range as described in further detailbelow. There can be certain items that a clinician has no control over,as indicated by the “Yes” and “No” 1617 that are hard coded into thesystem, with no ability for the clinician to change those values. Here,a clinician can only change the settings as far as the renal therapymachine 100 allows. Thus the renal therapy machine 100 may have machinelimits or ranges that the clinician must stay within.

Device program screen 1600 displayed on a clinician's display device 192in FIG. 16A illustrates that access type 1624 (discussed below) is notpatient editable. Access type, e.g., single needle (usually nightly),dual needle short daily, dual needle nocturnal, dual needle every otherday (“EOO”), and dual needle every other night (“EON”), is anoverarching parameter or feature that affects many other parameters orfeatures. It is also a, if not the, fundamental piece of the doctor'sprescription. The feature is accordingly locked as may other features beif for example changing such features would require the ranges of otherfeatures to be changed. A clinician may be also able to lock a categoryor a portion thereof so that another clinician cannot change thesetting. Or, an administrator for a clinic may lock a certain categoryor portion thereof so that no clinician can change the setting once itis set.

At device program screen 1600, the clinician can specify the deviceprogram name at entry box 1620, the dialyzer model that the patient isusing at drop-down menu 1622, the treatment or access type at drop- orscroll-down menu 1624 and the treatment duration at fields 1626, whichhave fields for both hours and minutes. Device program screen 1600 alsoallows a clinician to specify a setting range 1628.

It is advantageous to allow patients to tailor the renal treatment whenappropriate to their schedules and moods but do so within an allowedrange. For example, a patient may not be feeling well enough to run along treatment, may have a prior commitment, or in any case may want torun a shorter treatment. Allowing clinicians to specify acceptableranges and then letting patients choose the actual values run by machine100 allows patients to have some control and autonomy over thetreatment. Patient choice is important. In no case however, can apatient change a parameter setting outside of a range set by theclinician (per doctor's prescription), or change the range that theclinician has set. System 110 also forces the clinicians to stay withinthe machine limits described above. In other words, a clinician sets aspecific value and a range. The range specified by the clinician islimited by the machine. The patient can then alter the value within therange specified by the clinician.

FIG. 16B illustrates the blood flow tab 1606 of device program screen1600 displayed on a clinician's display device 192, which allows theclinician to specify single needle blood flowrate at selections 1630,double needle blood flowrate at selections 1632, positive pump pressureat entries 1634, and negative pump pressure at entries 1636. In theillustrated embodiment, blood flowrate allows the minimum and maximumrate to be set by the clinician, and the patient to pick a value inbetween.

Pump pressure is the pressure by which the blood and dialysate pumps(for hemodialysis), dialysate pumps (for peritoneal dialysis,substitution pups (for hemofiltration and hemodiafiltration), drug pumps(for drug delivery, and so on, are operated. If the pumps are pneumaticpumps, for example, the pressure is set by setting the pump's pneumaticoperating pressure.

FIG. 16C illustrates the dialysate tab 1608 of device program screen1600 displayed on a clinician's display device 192. Tab 1608 allows theclinician to specify dialysate flowrate at entries 1638 and thedialysate prescription at drop-down menu 1640. Dialysate flowrate is theflowrate at which dialysate is pumped to and from a dialyzer (forhemodialysis) or the patient (for peritoneal dialysis). Dialysateprescription relates to the chemical makeup of the dialysate used fortreatment, which is generally measured by measuring the conductivity ofthe dialysate.

FIG. 16D illustrates the fluid management tab 1610 of device programscreen 1600 displayed on a clinician's display device 192, which allowsthe clinician to specify the priming method at drop-down menu 1642, thetarget weight at entries 1644, maximum UF volume at entries 1646,maximum UF rate at entries 1650, rinseback volume at entries 1652, totalrinseback volume at entries 1654, fluid infusion volume at entries 1656,total fluid infusion at entries 1658 and additional fluid infusion atentries 1660.

The priming method can include whether or not the patient wishes toreplace priming fluid in the blood set with dialysate before treatmentis started. Target weight is the weight the patient wants to be at theend of treatment. Ultrafiltration is the amount of blood plasma or waterthat has to be removed from the patient over treatment for the patientto reach his or her target weight. UF rate is the rate at any given timeduring treatment that UF is being removed from the patient. Rinsebackvolume refers to the volume of fluid that is given at the end of thetreatment as part of the process to return the patients blood. Fluidinfusion volume to the volume of dialysate that can be given to thepatient in response to a hypotensive event.

FIG. 16E illustrates the heparin tab 1612 of device program screen 1600displayed on a clinician's display device 192. Heparin tab 1612 allowsthe clinician to specify whether to use integrated heparin via button1662, loading dose method at drop-down menu 1664, the loading dosevolume at entries 1666, the loading dose hold time at selections 1668,the heparin infusion rate at selections 1670, the heparin stop time atentries 1672 and the heparin bottle volume at entry 1674.

Loading dose hold time refers to the amount of time that the systemwaits after a heparin bolus is given to a patient prior to startingtreatment. Heparin rate is the rate at which heparin is delivered to theblood circuit during treatment. Heparin time refers to the time beforethe end of treatment that heparin delivery is stopped to allow thepatients blood to return to normal coagulation. Bottle volume sets howmuch heparin is available to be delivered over treatment.

FIG. 16F illustrates the backflush option tab 1614 of device programscreen 1600 displayed on a clinician's display device 192, which allowsthe clinician to specify the backflush volume at drop-down menus 1676and the backflush frequency at drop-down menu 1678. Backflush volume atdrop-down menu 1676 is the volume of dialysate that is sent to thedialyzer to prevent clotting of the dialyzer. This volume is also givento the patient. The renal therapy machine automatically compensates itsUF rate to remove this fluid, so from the fluid management standpointthere is a net zero fluid transfer. Backflush frequency at drop-downmenu 1678 is how often (in minutes) a backflush bolus is given, whichallows automating the delivery of the programmed backflush volume at thebackflush frequency rate throughout the treatment.

FIG. 16G illustrates the “Other” tab 1616 of device program screen 1600displayed on a clinician's display device 192, which allows theclinician to specify the stagnant blood time limit at drop-down menu1680, and the dialyzer clearance threshold 1682. The clinician can alsoset whether the patient can use a temporary disconnect 1684. Stagnantblood time at drop-down menu 1680 sets how long the blood pump can bepaused during treatment before treatment is stopped and rinsebackbegins. Dialyzer clearance threshold at drop-down menu 1682 sets aminimum clearance value for the dialyzer, which is reused in oneembodiment. Once the actual clearance of the dialyzer falls below acertain threshold, the dialyzer has to be replaced. Lowering thethreshold value thus increases the life of the dialyzer potentially, butallows for less clearance at the end of the life of the dialyzer.

At the temporary disconnect selection 1684, the clinician can decidewhether the patient can get off of the machine during treatment. Forexample, the patient may have to use the bathroom or attend to some taskduring treatment. If temporary disconnect is allowed, the patient canpause treatment, disconnect from the blood needles, and attend towhatever needs attention. Blood in the blood tubes is typically rinsedback to the patient before the patient can get off of the machine. Theclinician may not be comfortable yet with the patient rinsing back,disconnecting, and then reconnecting, and may therefore opt not to allowtemporary disconnect at selection 1250.

Once all the fields have been filled, the clinician selects a Submitbutton 1686 in FIG. 16G, which sends the settings entered on the deviceprogram screen 1600 displayed on a clinician's display device 192 to therenal therapy machine 100. In one embodiment, the clinician may berequired to identify himself or herself when the Submit button 1686 isselected to ensure that only an authorized clinician is making changesto the renal therapy machine 100's settings. Indeed, the clinician maybe required to enter an identification number to even begin makingchanges to an existing device program or making a new device program.Selecting the Submit button 1686 in one embodiment leads to a ConfirmScreen (not illustrated) that provides a summary of the device programsin a condensed, e.g., one page format. The clinician then confirms thateach setting for the device program is correct.

In one embodiment, Submit button 1686 does not send the device programto therapy machine 100. Instead, the Submit button 1686 sends the newdevice program to the device programs listed at device settings screen1500 (FIG. 15A) only. In this manner, the clinician can create multipledevice programs, each meeting a doctor's prescription, withoutnecessarily sending the device programs to machine 100. This allows anopportunity for afterthought and consultation by the clinician ifdesired. It is also expressly contemplated for the clinician to sendmultiple device programs to machine 100 for the same patient. Thepatient could thus have a device program for short, e.g., short daily,nocturnal, EON, EOD, to allow the patient to have flexibility, e.g.,from week to week.

The delete button 1688 allows a clinician to delete a specific device ortreatment program. In one embodiment, the clinician must confirm that heor she would like to delete the program before the program is actuallydeleted or removed from the patient's arsenal of treatment or deviceprograms. In one embodiment, the submit button 1686 and the deletebutton 1688 appear on each of tabs 1604 to 1616, so that the cliniciancan submit a program or delete a program from any one of tabs 1604 to1616.

As discussed above, while machine 100 will not run a treatment until thenew device program is approved by the patient, the patient still has toreview and accept the new device program before it is finally downloadfor operation via ACPU 112. Thus the patient can see if a new deviceprogram is questionable, e.g., if new settings depart radically from theold settings or if the patient is not comfortable with the new settings.The patient can contact the clinic and review the new device programs.

In one embodiment, once the settings are submitted and sent to the renaltherapy machine 100, the settings can only be changed with a clinicianpassword (FIG. 15C). The clinician specifies the clinician password atthe web portal 150 when selecting values for the parameters on deviceprogram screen 1200. If changes to the settings are to be made at therenal therapy machine 100 in the patient's home, the clinician firstenters the password. The settings may thereafter be changed.

As discussed above, templates are provided for convenient entry ofpreselected values. The template values may be changed to refine thedevice program. FIG. 17A illustrates an example device setting templatesscreen 1700 displayed on a clinician's display device 192 that can beused to prepare templates for various portions of the web portal 150.The device setting template screen 1700 allows a clinician to create,view and edit device program templates 1706 to be used to populatesettings when creating device programs, a patient settings template 1708to be used to populate patient settings, and a system settings template1710 to be used to populate system settings. Device setting templatescreen 1700 contains many of the same elements of device settings screen1500 (FIG. 15A) because the templates created using device settingtemplates screen 1700 can be used to populate values in the devicesettings screen 1500. The clinician can select links 1702 and 1704 tonavigate to device setting templates screen (FIG. 17A) and flag rulesscreens (FIGS. 17C to 17E).

FIG. 17B illustrates a template 1720 displayed on a clinician's displaydevice 192 that a clinician can use to specify values for the parametersand setting ranges described above in the general tab under deviceprogram screen 1600 (FIG. 16A). The clinician can specify the templatename in field 1712. Additional template screens (not shown) areavailable for each tab described in FIGS. 16B through 16G.

During a renal treatment, a large number of events take place, whichmachine 100 stores in its log files. Home medical device system 110provides a proficient way to notify clinicians regarding pertinenttreatment events and conditions. The clinicians can specify the eventsor conditions that are of most concern. When these events occur or whenthe conditions are met or not met, system 110 triggers and displaysrelevant notifications to the clinician who reviews the patient'streatment data.

FIG. 17C illustrates an example flag rules screen 1750 displayed on aclinician's display device 192 that allows the clinician to selectdifferent treatment events shown in column 1752 that will trigger anotification. The flag rules screen is illustrated as being organizedunder the templates portion of web portal 150, but may be organizedunder a different portion of the web portal 150. For each treatmentevent in column 1752, the flag rules screen displays instructions aboutthat event in column 1754 and the trigger for that event in column 1756.As illustrated in FIG. 17C, a clinician can set flag rules relating totreatment duration 1764, blood flow and blood volumes 1766, and fluidcontrol 1768.

Flag rules screen 1750 also allows the clinician to specify theparameters 1762 that either generate a first notification icon 1758 or asecond notification icon 1760. Flag rules screen 1750 enables theclinician to quickly specify or check off the different events orconditions that the clinician desires to trigger a flag or anotification on dashboard 1200 described in FIG. 12A. The clinician cancheck off or specify different values, related to the events in column1752, which trigger an alert. The different notification icons 1758 and1760 indicate the different alerts can be triggered. Notification icons1758 and 1760 are icons that will appear in the dashboard 1200. Thenotification icons 1758 and 1760 are explained in the legend screen 1250(FIG. 12B).

FIG. 17D illustrates that events related to system alerts, alarms orfaults 1770 can also trigger flag rules on flag rules screen 1750displayed on a clinician's display device 192. The clinician can submitor cancel the settings using submit button 1774 or cancel button 1772,respectively.

FIG. 17E illustrates an example of the setting of flag rules 1790displayed on a clinician's display device 192. In the illustratedembodiment, the clinician would like to be alerted on the dashboardscreen 1200, via the notification icons, when a short treatment hasended early 1776. The clinician sets parameters 1762 so thatnotification icon 1758 appears on the dashboard screen 1200 when atreatment is shortened by thirty minutes or more. The clinician can alsoset parameters 1762 so that notification icon 1760 appears on thedashboard screen 1200 when a treatment is shortened by, e.g., sixty,ninety, or one-hundred-twenty minutes or more.

User Management

FIG. 18A is an example screen shot of a users screen 1800 displayed on aclinician's display device 192. In one embodiment, only a clinicadministrator can access the users tab 1223. Upon selecting the userstab 1223, a clinic administrator is able to view a user list 1802,maintain a user 1804 and add a user 1806 on the left hand side of thescreen as illustrated in FIG. 18A. In the illustrated embodiment, theclinic administrator has selected view user list 1802, which appears asbeing high-lighted. In the user list, a clinic administrator can view anemail address or user name 1808, the name of the user 1810, the role ofthe user 1812, the status of the user 1814 and various actions 1816 thatmay be performed on that user entry in the user list.

A clinic administrator may select maintain user 1804 to maintaininformation about a specific user that has been selected. As illustratedin FIG. 18B illustrating a users screen 1800 displayed on a clinician'sdisplay device 192, when the maintain user link 1804 is selected, it ishigh-lighted to indicate it is currently selected. Selecting maintainuser 1804 displays three more tabs to the clinic administrator: userinformation 1818, site access 1820 and patient access 1822. On thescreen illustrated in FIG. 18B, the clinic administrator also may beable to remove a user using remove user button 1824. Once the clinicadministrator fills out or updates information about the user, theclinic administrator can submit the information using submit button1825.

The clinic administrator may also select site access tab 1820 to specifythe role of a user. A user may have more than one of the roles at thesame time. Each role unlocks or opens up certain features and abilitiesfor a user. The clinic administrator can specify how much control isgiven to a user based upon the role or roles selected for that user. Forexample, as illustrated in users screen 1800 displayed on a clinician'sdisplay device 192 in FIG. 18C, a user may be given or take on one ormore of four roles: a basic role 1826, a device management role 1828, adevice template management role 1830, and a user management role 1832. Abasic role 1826 gives a user the ability to view patient informationincluding treatment information, device settings and reports, includingthe dashboard screen 1200. A device management role 1828 gives a userthe ability to create and edit device settings. A device templatemanagement role 1830 gives a user the ability to create and edit clinicdevice templates and clinic flag rules. A user management role 1832gives a user the ability to create and edit clinic staff users. Multipleroles may be given to a single user to allow for progressive access tosystem 110. In the illustrated embodiment, the user Dr. John Parker hasbeen given the basic role, as indicated by the check box at selection1826.

The clinic user may also select patient access tab 1822 displayed on aclinician's display device 192 as illustrated in FIG. 18D. Patientaccess tab 1822 allows a clinic administrator to specify what type ofpatient access a user can have. A user may have no patient access, mayhave access to all patients, or may have limited patient access. When auser has limited patient access, that user can only access informationabout certain specified patients (not shown). For example, limitedpatient access may be used to give a doctor access to only his or herpatients. Clinic administrator may also be able to add a user using link1806 as illustrated in a users screen 1800 displayed on a clinician'sdisplay device 192 in FIG. 18E.

Reports

FIGS. 19 through 29 illustrate example reports that are presented to aclinician at web portal 150 displayed on a clinician's display device192. The reports can be accessed from the reports tab 1221 (FIG. 12A).FIG. 19 illustrates an example patient treatment history report 1900displayed on a clinician's display device 192 that allows the clinicianto view the history of the treatment for a patient in tabular formatincluding the treatment date 1902, the name of the device prescription(or device program) that was applied 1904, the average duration of thetreatment 1906, the average number of event flags 1908, the averagesystolic diastolic blood pressure before treatment 1910, the averagesystolic diastolic blood pressure after treatment 1912, the averagepulse before and after treatment 1914, the average weight before andafter treatment 1916, the average target weight 1918, the average UFvolume removed before and after treatment 1920 and the average UF rateper kilo before and after treatment 1922.

FIG. 20 illustrates an example patient usage report 2000 displayed on aclinician's display device 192 that allows a clinician to see the amountof product or consumables used by a specific patient over a specifiedtime frame. In the patient usage report 2000, the clinician can view thetreatment month 2002, the dialyzer used 2004, the blood treatment setused 2006, the acid concentrate used 2008, the bicarbonate concentrateused 2010, the water pre-filters used 2012 and the water distributionloop used 2014.

FIG. 21 illustrates an example dialyzer status report 2100 displayed ona clinician's display device 192 that allows the clinician to viewinformation about the dialyzer. The dialyzer status report 2100 allows aclinician to view the treatment date 2102, the dialyzer usage 2104, thepercentage decline for each treatment 2106, the duration of thetreatment 2108, the heparin hold time 2110, the heparin volume infused2100 and the heparin stop time 2114.

FIG. 22 illustrates an example clinic usage report 2100 displayed on aclinician's display device 192 that allows the clinician to view thevarious products or consumables used in a clinic. In the clinic's usagereport 2100, the clinician can view the treatment month 2202, thepatient name 2204, the patient's date of birth 2206, the therapyprovider patient ID 2208, the clinic patient ID 2210, the dialyzer 2212,the blood treatment set 2214, the acid concentrate 2216, the bicarbonateconcentrate 2218, the water pre-filters 2220 and the water distributionloop 2222.

FIG. 23 illustrates an example clinic vitals report 2300 displayed on aclinician's display device 192 that allows the clinician to view vitalstatistics about the clinic, including averages for the entire clinic,as well as per individual patient. The clinic vitals report 2300 allowsthe clinic to view the patient name 2302, date of birth for each patient2304, the therapy provider ID 2306, the clinic patient ID 2308, theaverage starting blood pressure 2310, the average ending blood pressure2312, the averaging starting pulse 2314, the average ending pulse 2316,the target weight for the last day of the month 2318, the blood volumeprocessed 2320, the amount of hours dialyzing 2322, the number oftreatments 2323 and the average volume removed per treatment 2326.

FIG. 24 illustrates an example clinic treatment history report 2400displayed on a clinician's display device 192 which displays to theclinician a patient name 2402, date of birth of the patients 2404,therapy provider patient ID 2406, the clinic patient ID 2408, thepatient status 2410, the therapy start date 2412, the number oftreatments 2414, the hours of treatment 2416 and the number of eventflags 2418.

FIG. 25 illustrates an example device prescription history report 2500displayed on a clinician's display device 192. The device prescriptionhistory report allows the clinicians to view when the settings for arenal therapy machine 100 were last modified 2502, who made themodification 2504. The device prescription history report 2500 thenlists the history of the various settings on different dates. The deviceprescription history report lists, for each date under 2502, thedialyzer model 2506, the treatment type 2508, the treatment duration2512, blood flowrate 2514, maximum positive and negative pump pressures2516 and 2518, maximum dialysate flowrate 2520, dialysate prescription2522, prime method 2524 and rinseback volume 2526.

FIG. 26 illustrates an example operator interventions report 2600displayed on a clinician's display device 192 that allows a clinician toview when and why alarms were raised during renal treatment, such asalarm timestamps 2602, the type of alert that was raised 2604, when anoperator acted 2606 and what the operator requested 2608.

FIG. 27 illustrates an example treatment snapshot export report 2700displayed on a clinician's display device 192 that displays, for varioustimes 2702, the systolic diastolic blood pressures before and aftertreatment 2704 and 2706, the pulses before and after treatment 2708 andthe weight before and after treatment 2710.

FIG. 28 illustrates an example daily complaints report 2800 displayed ona clinician's display device 192 that lists complaints entered in bypatients and FIG. 29 illustrates an example complaints reconciliationreport 2900 displayed on a clinician's display device 192 that lists thesteps taken to respond to complaints.

Barcode Reader

As illustrated in FIG. 1A, in one embodiment, tablet 122 includes acamera 136. Camera 136 may be used to read barcodes or other identifyingsymbols on or associated with supplies used with renal therapy machine100 or components of renal therapy machine 100. Camera 136 may be of anyof the following types: barcode, infrared, laser, thermal andthermographic.

Camera 136 is used in one embodiment to scan consumables. For example, apatient may receive a delivery of supplies or consumables to performtreatment with renal therapy machine 100. The consumables may be in acontainer, e.g., a bottle of heparin or a blood set in a bag, eachhaving a barcode or identifier containing information about theconsumable, e.g., the amount and concentration of the heparin, or thetype of dialyzer provided with the blood set. The patient can pointcamera 136 of tablet 122 at the barcode or identifier to photograph orscan the barcode or identifier and identify the concentration, amount,etc., of the heparin or the type, e.g., flex capacity, of the dialyzer.The software to identify the barcode or identifier is in one embodimentprovided by machine 100 to tablet 122 along with the tablet's operatingsoftware and user information software. The tablet 122 passes theheparin, dialyzer or other information to the renal therapy machine 100.ACPU 112 processes the information received concerning the heparin andverifies that the heparin concentration, amount, etc., is correctaccording to the prescription or device program downloaded onto therenal therapy machine 100. The same check can be made for the dialyzer,acid concentrate, bicarbonate concentrate or other disposable item asdesired. In one embodiment, the ACPU 112 accesses a lookup table storedin renal therapy machine 100, or alternatively accesses a device programstored in renal therapy machine 100, to ensure that the consumableassociated with the scanned or photographed barcode is the correctconsumable. It is contemplated for ACPU 112 to send to tablet 122, or tocause tablet 122 to recall, an animated picture of the consumables fordisplay on tablet 122 for visual verification.

In this manner, the ACPU 112 can verify that the consumable, e.g., theheparin bottle, that the patient intends to use with renal therapymachine 100 is the correct bottle according to the prescription datacontained in the device program. It should be appreciated that thetablet's camera 136 operating as an identifier or barcode reader canperform verification of consumables, so that the patient does not haveto manually inspect and verify that the correct consumables have beenshipped and selected. It is likely the case that multiple patientsacross home medical device system 110 use different concentrations oramounts of a consumable according to their different prescriptions anddevice programs. Thus there may be a possibility that the wrong type oramount of a consumable is shipped to a patient. Or, the patient may beprescribed multiple device programs that call for different types and/oramounts of the same consumable. The tablet 122's camera 136 operating asa barcode reader allows a patient using home medical device system 110to easily and reliably verify that the correct consumable is used for aparticular device program.

If consumable identification information sent from tablet 122 to machine100 does not match that of the patient's prescription, machine 100alarms in one embodiment and logs the event to be sent to the clinician.This mismatch is also displayed on tablet 122. The mismatch may be of atype that can be overridden and accepted by the patient if the patientwishes to continue with the current consumables. The patient may begiven the opportunity to select and scan a substitute consumable toclear the mismatch. In doing so, tablet 122 instructs the patient to usethe tablet camera 136 to take a photograph of the barcode or identifierof the substitute consumable. If the subsequent photograph produces aprescription match, treatment is allowed to continue and a consumablemismatch error corrected message is logged for delivery to a server.

Alternative Clinician Dashboard

Referring now to FIGS. 30A to 43D, various embodiments and aspects ofthe screens that the clinician sees are illustrated. Various featurestie the screens together in a way that is beneficial for the particulartasks that the clinician performs, such as therapy prescription andoptimization and patient treatment monitoring. The various featuresinclude remotely ordering supplies and setting prescriptions,reusability of templates, interdependency of values entered in differentscreens, the prevention of the entry of inconsistent values for renaltherapy parameters and controlling the flow of data, including, forexample, prescription settings, log files documenting treatments andfirmware upgrades, between therapy machines at patients' homes and asystem hub via a connectivity agent that turns communication on and off.At least some of these features described in FIGS. 30A to 43D may beused in connection with FIGS. 10 to 18E.

FIG. 30A is an example dashboard screen 3000 for a clinic displayed on aclinician's display device 192 (FIG. 1B). Dashboard screen 3000 is inone implementation a screen that a clinician sees upon logging into theweb portal 150. Similar to dashboard screen 1200 (FIG. 12A), dashboardscreen 3000 provides an overview of information about the patientshandled by a particular clinic. The dashboard presented to a cliniciancan differ depending upon the type of renal therapy provided to apatient. For example, dashboard screen 1200 is presented to a clinicianto display information about patients receiving home hemodialysis viarenal therapy machine 100, while dashboard screen 3000 is presented tothe same or different clinician to display information about thepatients receiving peritoneal dialysis via renal therapy machine 100. Itis contemplated for dashboard 1200 (FIG. 12A) and 3000 (FIG. 30A) tohave a button or input device that allows the clinician to switch fromone type of dashboard (e.g., hemodialysis) to another type of dashboard(e.g., peritoneal dialysis). This would be used on a machine that couldrun either treatment on a given day, for example, as set forth in U.S.patent application Ser. No. 13/828,731, filed Mar. 14, 2013, entitled“System and Method for Performing Alternative and Sequential Blood andPeritoneal Dialysis Modalities”, the entire contents of which areincorporated herein by reference and relied upon.

The clinician's display device 192 may alternatively display a unifieddashboard that includes hemodialysis patients and peritoneal dialysispatients. It is contemplated for the unified dashboard to indicatewhether a patient is a hemodialysis patient or a peritoneal dialysispatient, and to allow the clinician to filter patients by therapy type,for example, based on whether patients receive hemodialysis orperitoneal dialysis therapy. Dashboard screen 3000 may also allow theclinician to sort by therapy sub-category, such as by an automatedperitoneal dialysis patient versus a continuous ambulatory peritonealdialysis patient. In another example, the clinician can sort by singleneedle nighttime versus dual needle daily hemodialysis.

In FIG. 30A, the patients are listed by name as shown at column 3002.Similar to dashboard screen 1200 (FIG. 12A), dashboard screen 3000 mayenable the clinician to apply filters as illustrated by drop-down menus3012 and 3013. For example, the clinician in the illustrated embodimentcan filter information in the dashboard by patient type (notillustrated, but type may be male or female, age, solute transport type,receiving hemodialysis or peritoneal dialysis, etc.), by attendingphysician at drop-down menu 3012, or by a treatment progress atdrop-down menu 3013. As indicated by item 3014, the dashboard screen3000 can report information about the treatments occurring in aspecified date range, e.g., Jul. 25, 2011 to Jul. 31, 2011 in theillustrated embodiment.

Various icons 3004, 3006, 3008 and 3010 indicate information about atreatment performed by that patient on a specific date. The icons mayindicate different types of events similar to the icons on dashboardscreen 1200 (FIG. 12A). In the illustrated embodiment, a check-mark icon3004 means treatment proceeded as planned that day. A flag with oneexclamation point icon 3006 indicates events that are not critical anddo not need immediate action, but need to be closely monitored in thefuture. A flag with two exclamation points icon 3008 may indicate eventsthat need immediate action. The X icon 3010 indicates that there hasbeen no communication with the machine 100 associated with that patientfor a specific treatment.

Dashboard screen 3000 may also include navigational tabs to allow theclinician to access various portions of the web portal 150. For example,navigational tabs in dashboard 3000 may include a clinical tab 3015, acustomer service tab 3016, a reports tab 3017, a clinic settings tab3018 and a users tab 3019. A clinician can access different portions ofthe web portal 150 by selecting an associated navigational tab. Thenavigational tabs appear on multiple screens at all times in one exampleembodiment and thus serve to tie the different dashboard screenstogether. Certain tabs of screen 3000 may only appear if the currentuser has been given access to those tabs, based for example upon whetherthe user is a patient, clinician or a clinic administrator.

Tab 3015 is used to access patient snapshots and treatment summaryscreens and view and edit device settings for the patients handled by aparticular clinic, as well as to return to dashboard 3000 if the userhas navigated away from dashboard 3000. Tab 3016 is used to view andedit information such as contact and delivery information, therapy,solution and disposables information, and order information about anindividual patient, and to add additional patients to the list ofpatients handled by a particular clinic. Tab 3017 is used to viewvarious reports relating to patients, clinics, components of therapymachines and events that occur during treatments. Tab 3018 is used toview and edit device settings templates and flag rules that generateflags on the dashboard 3000. Tab 3019 is used to view, maintain and addauthorized users that can access some or all of the various screensdescribed below.

As illustrated in FIG. 30B, patient popup 3020 appears on dashboardscreen 3000 when the clinician clicks on one of the patients listed incolumn 3002. Patient popup 3020 provides additional information 3022about the selected patient as well as a calendar view 3024 that providesicons and thus treatment outcome information for an entire month oftreatment for the selected patient. Patient popup 3020 may also allow auser, e.g., a clinician, to access a patient snapshot via link 3026 orview device settings via link 3028. Patient snapshot 3026 and the devicesettings via link 3028 are described in detail below.

Referring again to FIG. 30A, a user is able to access a legend usinglink 3018 similar to link 1218 in dashboard screen 1200 (FIG. 12A). Whena user selects legend link 3018, a popup window or new screen 3050appears. FIG. 30C illustrates an example legend screen 3050, which isprovided on a clinician's display device 192 to explain the meaning ofthe various icons that can appear on dashboard screen 3000. As discussedabove, icon 3004 indicates that the treatment went “Ok.” Icon 3006indicates a flag of normal priority. Icon 3008 indicates a high priorityflag. Icon 3010 indicates that there was no communication with the renaltherapy machine 100 associated with that patient for a particular day.

Icon 3011 is a treatment review indicator that indicates whether aclinician has reviewed the treatment associated with the treatmentreview indicator. For example, in the illustrated embodiment, thetreatment review indicator 3011 indicates to a clinician that the Jul.30, 2011 treatment has already been reviewed by a clinician. Thus, aclinician viewing the dashboard is informed that the Jul. 30, 2011treatment marked with a high priority flag 3008 has already beenreviewed. Treatment review indicator 3011 also serves as a record thathigh priority flags 3008 has been reviewed. Without the treatment reviewindicator 3011, each time a clinician logs in and views the dashboard,the clinician may see various flags, some of them requiring immediateattention, but would not know whether the flags have already beenreviewed.

Icon 3012 indicates that the patient performed multiple treatments on acertain day. One or more of the icons, including flag icons 3006 and3008, can be selected to view more detailed information concerning theicon. Selecting the flag, for example, causes the reason for the flagoccurring during a particular treatment to be displayed to theclinician.

Referring again to FIG. 30B, and as described above, the patient popup3020 may include a view patient snapshot link 3026 and a view devicesettings link 3028. FIG. 31A illustrates an example patient snapshotscreen 3100 displayed on a clinician's display device 192 that can belaunched from link 3026. The patient snapshot screen 3100 providesdetailed information to the clinician about an individual patient, e.g.,about peritoneal dialysis treatments that were performed by renaltherapy machine 100 on the patient. The clinician may filter informationby selecting a timeframe using drop-down menu 3102. In the illustratedembodiment, the clinician has selected to view treatment data over atimeframe of seven days. Calendar 3106 displays a calendar view of theicons discussed above for the seven days in which data is viewed. A linkto a legend 3104 is again provided on patient snapshot screen 3100,which displays the same icons and explanations for icons as describedabove in FIG. 30C.

The patient snapshot screen 3100 provides information such as the 24hour ultrafiltrate volume 3108 and the patient weight before and aftertherapy 3110. The information displayed on snapshot screen 3100 mayprovide multiple items of information in the same graph. For example,chart 3108 provides a bar indicating how much ultrafiltrate was removedover the course of twenty-four hours. The bar is made up of threedifferent colors or shades. As indicated by key 3109, each shaderepresents a different way in which the ultrafiltrate was removed, e.g.,how much ultrafiltrate was removed by renal therapy machine 100 duringthe day and during the night, as well as how much ultrafiltrate wasremoved via manual peritoneal dialysis exchanges.

Similarly, in chart 3110, each graph indicating the patient's weight fora day indicates the patient's weight before and after treatment. Asillustrated in key 3111, the darker bar graph for a day indicates thepatient's weight before treatment and a lighter or different colored bargraph indicates the patient's weight after treatment. Chart 3110 couldalso display blood pressure and/or glucose level data for the patient onthe highlighted days, for example.

FIG. 31B illustrates additional information that may be displayed on thepatient snapshot screen 3100 displayed on a clinician's display device192. Patient snapshot screen 3100 for example displays a blood pressurechart 3112 and a pulse or beats per minute chart 3114. The bloodpressure information chart 3112 contains four types of blood pressurereadings for each displayed day. As indicated by key 3113, for example,each graph for a day indicates a pre-systolic blood pressure indicatedby the diamond-shaped icon, a pre-diastolic blood pressure informationas indicated by the square icon, a post-systolic blood pressure asindicated by the triangle icon and a post-diastolic blood pressure asindicated by the circle icon. Pulse chart 3114 also indicates differentinformation related to a patient's pulse before and after peritonealdialysis treatment as indicated by key 3115. For example, the graph foreach day indicates a pre-treatment pulse indicated by a diamond-shapedicon and a post-treatment pulse as indicated by the square icon. Theblood pressure and pulse readouts may be instantaneous readoutsindicating a single sample taken at a single point in time or be anaverage readout taken and averaged over multiple points in time.

It should be appreciated that the patient snapshot screen 3100 thereforeallows a clinician to quickly view and visually assess how treatmentshave been performed for a specific patient over a defined period oftime. The clinician can easily view data regarding the variousparameters related to therapy, e.g., peritoneal dialysis. For example,the clinician can see a breakdown of the how the ultrafiltrate removalhas progressed and can also visually assess the patient's weight, bloodpressure, and pulse both before and after treatment. Although patientsnapshot screen 3100 is displayed across FIGS. 31A and 31B, in oneembodiment, all of patient snapshot screen 3100 is displayed to theclinician at the same time on clinician's display device 192. Otherscreens described elsewhere that may be divided across multiple figuresfor convenience may also likewise be presented to the clinician as onecontinuous scrollable screen on clinician's display device 192.

FIG. 32A illustrates an example treatment summary screen 3200 onclinician's display device 192. Summary screen 3200 provides granulateddetails about a particular treatment. Treatment summary screen 3200 canbe launched by selecting one of the dates on calendar 3106 of FIG. 31A.In the illustrated embodiment, the user has selected Mar. 11, 2012, asindicated in chart 3208. From treatment summary screen 3200, a cliniciancan see a description of the flag symbols at chart 3202. The cliniciancan also see a description of any deviation from planned treatment atchart 3204 and alerts that occurred during a treatment, e.g., aperitoneal dialysis treatment, at chart 3206. The clinician can also seethe date and time of treatment as indicated at chart 3208, theprescribed device program at chart 3210, and an overall treatmentsummary log in table format showing exact times for various treatmentevents at chart 3212. Chart 3212 along with its treatment summary logmay be printed and added to a patient's file. In the illustratedembodiment, information about the cycles that make up a peritonealdialysis treatment are displayed in chart 3212. Chart 3212 displays abeginning time of each cycle as a well as a fill volume, fill time,dwell time, drain volume, drain time and UF removed for each cycle.

The screen 3200 displayed on a clinician's display device 192, includingchart 3212, is continued in FIG. 32B. As shown in FIG. 32B, a cliniciancan also see manual peritoneal dialysis exchange particulars in chart3214, and a summary of physical parameters before and after treatment inchart 3216. The clinician can also see the device ID of the renaltherapy machine 100 and the software version of the renal therapymachine 100 at chart 3217. The clinician can likewise see device programsolutions at chart 3218 and device program details at chart 3220. Thesolution data, e.g., for peritoneal dialysis, includes volume anddextrose levels. The device program data includes how machine 100 hasbeen programmed to operate for the particular day or treatment, and mayinclude multiple treatments per day for peritoneal dialysis.

FIG. 33 illustrates an example device settings screen 3300 displayed ona clinician's display device 192, which can be launched from thedashboard screen 3000 (FIG. 30B). Similar to device settings screen 1500of FIG. 15A, device settings screen 3300 displays relevant consolidatedinformation about the various device programs, patient settings andsystem settings being used to run a peritoneal dialysis machine 100, andalso provides a consolidated location or screen for clinicians to accessvarious aspects of the patient care. From the device settings screen3300, a clinician may be able to access information about deviceprograms 3302, patient settings 3304 or system settings 3306. Underdevice programs 3302, a clinician can view all of the different deviceor machine operation programs stored for that patient, e.g., forperitoneal dialysis. A clinician may be able to create a new deviceprogram for that patient using link 3308. The clinician can also editexisting device programs 3302, patient settings 3304 and system settings3306 using the links in the action column 3310. Similar to the devicesettings screen 1500 of FIG. 15A, device settings screen 3300 alsoindicates the last person to modify any of the device programs, patientsettings or system settings as shown in the modified by column 3312. Thedate of the modification is shown in the modified on column 3314.

FIGS. 34A to 34F illustrate an example device program screen 3400displayed on a clinician's display device 192, which allows cliniciansto set values for parameters that control how a dialysis treatment suchas a peritoneal dialysis treatment will be performed at the patient'shome. Similar to device program screen 1600 illustrated in FIGS. 16A to16G, device program screen 3400 illustrates fields or parameters thatare specified by a clinician that are the product of a doctor'sprescription for the patient. A clinician can name the device programusing field 3402. As with device program screen 1600, the device programscreen 3400 also provides an option for the clinician to apply templatesat scroll-down menu 3404. As before, the templates are convenientbecause templates allow the clinicians to enter preselected values formultiple parameters at once by selecting a template.

The device program screen 3400 contains various tabs, such as a time tab3406 (FIG. 34A), a volume tab 3408 (FIG. 34B), a settings tab 3410 (FIG.34C), a solutions tab 3412 (FIG. 34D), and a patient editable settingstab 3414 (FIGS. 34E to 34G). In one embodiment, the fields displayedacross the various tabs are inter-related. For example, the valuesentered into the time tab 3406, volume tab 3408, settings tab 3410,solutions tab 3412 and patient editable settings tab 3414 all worktogether, depend on and influence each other. It is contemplated for asecond one of tabs 3406 to 3414 to display values that are acceptablebased upon what the clinician entered under a first one of the tabs 3406to 3414. The user accordingly need not be concerned with calculating ordetermining what values may be available for entry based upon what theuser has already entered and selected in other previous tabs. Theclinician's computer in operation with home medical device system 110performs the calculations for this use and only allows entry andselection of valid values under the tabs. For example, only valuesavailable for selection may be displayed under the tabs. The cliniciantherefore need not be concerned with verifying whether the valuesentered and selected are consistent with each other.

In FIG. 34A, the clinician has selected and may enter values into fieldsin the time tab 3406. Here, the clinician can select and enter valuesfor either a night therapy time 3416 or a night dwell time per cycle3418. The clinician enters values for the displayed hours and minutesfields. The clinician also has the ability to enable a treatment option,such as smart dwells option 3420, which provides more control over thedwell time during the night portion of peritoneal dialysis therapy.Enabling smart dwells 3420 allows a clinician to select parameters thatcomport with the patient's lifestyle. When smart dwells is set to“Enabled”, the renal therapy machine 100 adjusts the dwell time toaccommodate changes in the fill and drain times, so that the treatmentends as scheduled. When smart dwells is set to “Disabled”, the therapydwell times are not changeable, therefore, the treatment may end at adifferent time then scheduled.

FIG. 34B illustrates that the clinician has scheduled the volume tab3408 of device program screen 3400 displayed on a clinician's displaydevice 192 which allows the clinician to specify if the treatmentincludes a day therapy 3422, a night therapy 3424, a tidal therapy 3426or a last fill 3428. If any one of items 3422, 3424, 3426 or 3428 isselected as “Yes”, the clinician enters a volume and a number of cyclesfor the selected item. The clinician's computer in operation with system110 in one embodiment then multiplies the volume times the number ofcycles to determine and display an aggregate volume for that option. Thedevice program screen 3400 uses programmed logic stored in theclinician's computer to determine what values may be entered undervolume tab 3408 based upon the values entered into the time tab 3406.The clinician may for example not be able to enter a particular volumeor a number of cycles if that particular volume and/or number of cyclescannot be safely used or performed in the amount of time specified inprevious tab time tab 3406.

It should therefore be appreciated that the dashboard 3400 onclinician's display device 192 allows a clinician to safely specify theparameters that will actually work for a given patient by onlypresenting fields that can be filled and only allowing the entry ofvalues that can work or be performed with other selected values and/orthe patient's prescription. Home medical device system 110 accordinglyremoves the burden from the clinician of having to ensure that theselected values are all consistent.

To accomplish the goal of relieving the clinician of having to verifyall settings against one another, it is contemplated to make one or moretabs 3406 to 3416 sequentially dependent on one or more other tabs. Inone example, the clinician can only proceed from the time tab 3406 tothe volume tab 3408 after values have been specified in the time tab3406, e.g., at least one of night therapy time 3416 and night dwell time3418 have been selected by clinician and the associated amount of timein hours and minutes has been entered by the clinician. The valuesentered into the time tab 3406 limit the values that may be entered intosubsequent tabs. The clinician then specifies information in the volumetab 3408, which may further limit or inform the values that can beentered in the settings tab 3410 and the solutions tab 3412. In thismanner, the clinician is presented with a smart system in which thescreens and fields that are presented to the user depend upon valuesentered in previous screens. It should therefore be appreciated thatdashboard 3400 allows the clinician to specify one aspect of treatmentat a time, which then influences the parameters that can be entered forother aspects of the treatment.

The smart system can use machine limitations and/or therapy limitationsto help filter the values available in subsequent tabs. For example,once time is entered, available volume can be limited by knowing a safemaximum flow rate for machine 100, e.g., how fast can machine 100 fillor empty the patient in a peritoneal dialysis therapy. In anotherexample, a particular type of solution may require a minimum dwell timeto ensure that the benefit provided by the solution is used effectively.These types of rules are implemented on the clinician's software, whichmay be stored thereon by downloading the software via system hub 120 andweb portal 150 to the clinician's computer.

Referring back to FIG. 34B of device program screen 3400, the clinicianenters the needed information in the volume tab 3408 and presses next.FIG. 34C displays an example settings tab 3410. The clinician is askedto enter values for an estimated maximum peritoneal volume 3430, anestimated night ultrafiltrate 3432, whether the last fill solution isthe same as or different from the night fill solution 3434 and a minimuminitial drain volume 3436. The maximum peritoneal volume 3430 may be anestimated volume that a patient's peritoneal cavity can accept forperitoneal dialysis. This volume is used to determine when partialdrains are not adequate. The settings tab 3410 may recommend an amountto enter for the maximum peritoneal volume 3430 field based upon thebody mass of the patient. As described above, the values that can beentered in the fields in settings tab 3410 can alternatively depend uponthe time and volume amounts previously specified by the clinician intime tab 3406 and volume tab 3408, respectively. For example, estimatedUF depends on solution volume, solution type and dwell time.

The clinician may also be able to access advanced settings by pressingbutton 3438. Advanced settings may include additional settings fortailoring treatment for a particular patient, thereby increasingconvenience and satisfaction for the patient. Advanced settings mayinclude an option for enabling an effluent sample reminder, which pausestherapy before emptying solution bags at the end of treatment to allow apatient to collect an effluent sample before the unused solutions dilutethe sample (assuming unused solution is collected with drainedeffluent). Advanced settings may also include an option for enabling anextra last drain mode, which is designed to ensure that a patient iscompletely drained before his or her last fill volume is delivered, andan extra drain UF limit, which is a percentage setting indicating thepercentage of expected night UF needed before the patient receives theextra last drain mode option. Advanced settings may also include anoption for enabling an extra last drain alert, which occurs at the endof the last drain and prompts the patient to press a confirm button onrenal therapy machine 100 before receiving the last fill volume.

Advanced settings may further include an option for (i) modifying aminimum initial drain time, which is the minimum length of time allowedto complete an initial drain, (ii) modifying a minimum night drain time,which is the minimum length of time allowed to complete a night drain,(iii) modifying a minimum day drain time, which is the minimum length oftime allowed to complete a day drain, and (iv) modifying a minimum daydrain volume percentage, which is the percentage of day fill volume thatneeds to be drained before moving to next phase of therapy.

FIG. 34D of device program screen 3400 illustrates that the user haspressed a solutions tab 3412 (FIG. 34A) which allows a clinician tospecify solution bag volumes 3440 and view a programmed therapy volume3442. The clinician can specify the solution bag type (e.g., Dianeal,Extraneal, etc.), the glucose percentage or concentration (e.g., 1.5%,2.5%, 4.25%, etc.) and the bag volume (e.g., 1000 mL, 2000 mL, 5000 mL,6000 mL, etc) in solution volumes 3440 that should be used by thepatient for treatment. Again, the values that can be entered by theclinician depend upon the values that have been previously entered intotime tab 3406, volume tab 3408 and settings tab 3410. The programmedtherapy volume 3442 in one embodiment displays for convenience theamount of the solution volume the clinician has programmed, e.g., inother tabs.

The solution volumes 3440 is the volume of solution for one days' worthof treatment. Thus the clinician must select a solution volume, thetotal programmed solution volume of all the lines set by the clinicianin solution volumes 3440 (FIG. 34D), that is greater than or equal tothe programmed therapy volume, which is made up of the sum of the volumeused during day therapy (specified in field 3422 of FIG. 34B), duringnight therapy (specified in field 3424 of FIG. 34B), and in a last fill(specified in field 3428 of FIG. 34B). In one embodiment, theclinician's display device displays an error message if the solutionvolume is not greater than or equal to the programmed therapy volume3442.

FIG. 34E illustrates an example screen shot under patient editablesettings tab 3414 (FIG. 34A) displayed on a clinician's display device192. The clinician uses patient editable settings tab 3414 to specifywhether or not a patient can modify certain values. Similar to theranges described in connection with device program screen 1600 of FIG.16A, patient editable settings tab 3414 allows the clinician to specifywhether a patient can edit or modify certain parameters of thetreatment. The clinician specifies in drop-down menu 3444 which patientscan modify which parameters. If the clinician selects “Yes” in drop-downmenu 3444, a list 3446 of parameters that may be edited by the patientis displayed. For each parameter in list 3446, the clinician can selectin column 3448 whether or not the patient can edit that parameter. Inthe illustrated example, a clinician can decide whether or not a patientcan edit the duration of night therapy 3450, the night dwell time percycle 3452 or aspects about the volume 3454 such as day fill volume,number of day cycles and night fill volume.

The screen 3400 displayed on a clinician's display device 192, includinglist 3446, is continued in FIG. 34F. As shown in FIG. 34F, the clinicianmay also decide that a patient can edit additional aspects about thevolume such as the number of night cycles, night therapy volume, lastfill volume, tidal full drain frequency, tidal volume percentage and thenumber of added cycles. The clinician may also decide that a patient canedit settings 3456, such as whether to apply an extra last drain alert,whether to apply an extra drain UF limit and whether a fluid samplereminder is enabled or disabled. The clinician may also decide that apatient can edit information about solutions 3458, such as for example,the solution volume.

If the clinician allows the patient to edit values for a parameter, theclinician selects “Yes” next to that parameter in column 3448. As shownin FIG. 34G, system 110 displays additional fields next to a parameterwhen “Yes” in column 3448 is selected for that parameter. In theillustrated example, the clinician has decided to allow the patient toedit the night therapy volume, last fill volume, and tidal volumepercent. The clinician then sets a range in column 3460 between whichthe patient can choose for each parameter. System 110 may preclude aclinician from entering certain values into column 3460 if those valuesare inconsistent with values previously entered into other fields inother tabs. The patient can only choose a value for a parameter at orwithin the limits entered by the clinician. System 110 advantageouslyallows patients to tailor therapy under the system, such as peritonealdialysis, depending upon patient schedules and desires, but to do sowithin a safe, allowed range.

FIG. 34H illustrates a device program confirmation screen 3470 thatallows a clinician on one screen to view and confirm the valuesspecified using the tabs in the device program screen 3400 (FIGS. 34A to34G). The device program confirmation screen 3470 may be accessed bypressing the review button on the patient editable settings tab 3414(FIGS. 34E to 34G) in the device program screen 3400. FIG. 34H allowsthe clinician to verify the settings all together before actuallysubmitting the settings to renal therapy machine 100 at the patient'shome via the connectivity server 118. As indicated at message 3464, anasterisk indicates that a setting value has been modified by theclinician as opposed to using a default value. The device programconfirmation screen 3460 displays a settings summary table 3466 thatlists all the values for the parameters, a patient settable range andwhether or not the clinician will allow the patient to edit thosevalues. Device confirmation screen 3470 allows the clinician to view ata high level and in summary format all of the different settings thathave been selected via device program screen 3400 (FIGS. 34A to 34G).After reviewing table 3466 for accuracy and correctness, the cliniciancan submit the settings to the patient's device via connectivity server118 by pressing submit button 3468. Once submit button 3452 is selected,the values and parameters are forwarded to renal therapy machine 100 viaconnectivity service 118 as described above.

As described above, the device program screen 3400 allows a clinician tocontrol the treatment provided by machine 100. Patient settings screen3500 described below in connection with FIG. 35A allows a clinician tospecify whether the patient is to perform a task such as check his orher weight, pulse, blood pressure, glucose and temperature or whether amanual exchange is performed. The patient settings screen 3500,illustrated in FIG. 35A, may be accessed on a clinician's display device192 from device settings screen 3300 (FIG. 33). As with patient settingsscreen 1530 (FIG. 15B), changes made in the patient settings screen 3500modify how the next treatment is performed but are not immediatelyreported to the system hub 120. In the patient settings screen 3500, theclinician can apply a clinic template 3502 which again allows theclinician to quickly and easily populate a group of pre-selectedsettings on patient settings screen 3500. In any case, patient settingsscreen 3500 enables the clinician to specify a setting for the weight3504, the pulse 3506, blood pressure 3508, glucose 3510, temperature3512 and manual exchanges 3514. The clinician can use the cancel button3516 and submit button 3518 to cancel or submit respectively the patientsettings selected on patient settings screen 3500. In an embodiment, apatient may be able to access the patient settings screen 3500 to modifyvarious settings for peritoneal dialysis treatment.

FIG. 35B illustrates a patient settings confirmation screen 3550. FIG.35B also illustrates the type of data that is set by patient settingsscreen 3500, namely, when the patient is to perform a task. For example,FIG. 35B shows that the patient weighs himself/herself before and aftertreatment. Blood pressure and heartbeat are measured after treatment.Blood glucose is measured before and after treatment. Patienttemperature is not taken in the illustrated embodiment, but can be ifdesired. These patient settings tell machine 100 when to prompt thepatient for such information. Patient settings confirmation screen 3550may be accessed by pressing the submit button on the patient settingsscreen 3500 (FIG. 35A). Table 3552 summarizes the values selected atpatient settings screen 3500 so that the clinician can review thesettings before submitting the settings to the patient's device viaconnectivity server 118. Patient settings confirmation screen 3550allows the clinician to view at a high level and in summary format allthe different settings that have been selected. After reviewing table3552 for accuracy and correctness, the clinician can submit the settingsto the patient's device via connectivity server 118.

FIG. 36A illustrates an example screen shot of a system settings screen3600 displayed on a clinician's display device 192. The system settingsscreen 3600 allows a clinician to specify various settings related toalarms and outputs renal therapy machine 100 makes. Outputted sound canbe raised for patients with hearing disabilities. Voice guidance helpingthe patient with set-up can be activated. The clinician can apply aclinic template 3602 which, like before, enables the clinician toquickly and easily specify and populate a group of pre-selected machineor system settings. The system settings screen 3602 allows a clinicianto select system settings for various aspects of the patient's devicevia sounds tab 3604, display tab 3606, format tab 3608, and general tab3610. Under the sounds tab 3604 illustrated in FIG. 36A, the cliniciancan specify an alert sound level 3612, a sound effect level 3614, atreatment end alert 3616, voice guidance 3618, and voice level 3620.Again, the sound may be adjusted based on patient hearing ability. Or,alarm sounds may be set higher than the sound level for standard therapysounds, e.g., sound effects or voice guidance, to activate the alarmoutput.

FIG. 36B illustrates display tab 3606 in system settings screen 3600displayed on a clinician's display device 192. At the display tab 3606,the clinician can specify a day brightness level 3622, a nightbrightness level 3624 and display auto-off 3626, which sets whether thedisplay of machine 100 (which may be a dedicated screen for peritonealdialysis, for example, instead of a tablet 122 for hemodialysis, forexample) goes into a hibernate mode after a certain period of time. FIG.36C illustrates an example screen shot of format tab 3608 in systemsettings screen 3600 displayed on a clinician's display device 192. Atthe format tab 3608, the clinician can specify a date format 3628, atime format 3630, a number format 3632, weight units 3634, temperatureunits 3636 and blood glucose units 3638. Format accordingly generallyapplies to data format.

FIG. 36D illustrates an example screen shot of a general tab 3610 insystem settings screen 3600 displayed on a clinician's display device192. On the general tab 3610, a clinician can specify fluid temperature3640, a user mode 3642 and the language 3644. Fluid temperature 3640controls the temperature of the fluid warmer and the temperature of thefluid that will be infused into the patient. User mode 3642 allows theuser to consolidate the treatment screens as the user's expertise grows.Language 3644 sets the language in which text is displayed and words areenunciated. Each of the screens for tabs 3606, 3608 and 3610 is alsoprovided with a clinician's template option to auto-populate therespective settings.

FIG. 37A illustrates an example screen shot of a device settingstemplates screen 3700 displayed on a clinician's display device 192. Thedevice settings template screen 3700 is accessed from clinic settingstab 3018 (FIG. 30A) and allows a clinician to view all the differenttemplates that are accessible to the clinician throughout web portal150. As explained previously, templates allow a clinician to enterpre-selected values for multiple parameters at once. The clinician canfilter the templates that are displayed on device settings templatesscreen 3700 and thus throughout web portal 150 by using drop-down menu3702 to filter by device version or drop-down menu 3704 to filter bysettings type. The device version 3702 allows a clinician to filtertemplates according to different software versions or hardware versionsthat are installed on machine 100. The settings type 3704 allows aclinician to filter the different types of templates, such as, deviceprogram templates, patient settings templates or system settingstemplates. The clinician can also create a new template using create newbutton 3706.

Once the templates are filtered according to the clinician's selectionsat drop-down items 3702 and 3704, the device settings templates screen3700 displays table 3708 which lists the various templates that remainavailable to the clinician. Table 3708 lists the name of the template incolumn 3710, device version of the template in column 3712, setting typeof the templates in column 3714, last user to modify the template incolumn 3716, date that the template was modified in column 3718, andactions that a clinician is allowed to perform on a template, such as toview or edit a template, in column 3720.

FIG. 37B illustrates an example screen shot of a device program templatescreen 3750. The clinician arrives at screen shot 3750 by selecting oneof the device program templates to view or edit on device settingstemplates screen 3700 (FIG. 37A). The device program template screen3750 displays the template name 3752 and different tabs that correspondto the selected template. For example, device program template screen3750 displays time tab 3754, volume tab 3756, settings tab 3758,solutions tab 3760, and patient editable settings tab 3762. The tabs andfields displayed in FIG. 37B correspond to the tabs and fields displayedin FIGS. 34A to 34G. It should therefore be appreciated that the valuesstored as part of a template in device program template screen 3750 canbe recalled quickly by selecting field 3404 on device program screen3400 (FIG. 34A). The values set at template screen 3750 can be averagevalues for all or many patients as opposed to values customized for asingle patient.

FIG. 38A illustrates an example flag rules screen 3800 displayed on aclinician's display device 192. Similar to example flag rules screen1750 (FIGS. 17C and 17D), flag rules screen 3800 allows a clinician toselect different treatment events selected from column 3802 that willtrigger a flag notification, which will then be displayed on dashboard3000 (FIG. 30A). For each treatment event in column 3802, the flag rulesscreen 3800 displays how the flag is set in column 3804 and the triggerfor the flag event in column 3806. Flag rules screen 3800 allows theclinician to specify the parameters 3812 that generate a first levelnotification icon 3808 or a second level notification icon 3810. Similarto flag rules screen 1750 of FIGS. 17C and 17D, flag rules screen 3800allows the clinician to quickly specify or check off the differentevents or conditions that the clinician desires to trigger a flag ornotification on dashboard 3000 described in FIG. 30A. As illustrated inFIG. 38A, a clinician can set flag rules relating to treatment duration3814 and treatment variances 3816. Flag rules screen 3800 is continuedin FIG. 30B, which illustrates that the clinician can also set flagrules relating to fluid control 3818, patient intervention 3820, systemalerts 3822, and treatment deviations 3824. Each of the flag rules isdescribed in sufficient detail in connection with FIGS. 31A and 31B. Theclinician can cancel the settings or submit the settings using cancelbutton 3826 or submit button 3828 respectively.

FIG. 39A illustrates an example screen shot of a patient list 3900displayed on a clinician's display device 192. Patient list 3900 isaccessible from tab 3016 (FIG. 30A). The clinician can view a list ofpatients in table 3902 in FIG. 39A. As illustrated in FIG. 39A, theclinician can view the patient's name 3904, a therapy mode 3906, thepatient's date of birth 3908, the clinic patient ID 3910, the status ofthe patient, such as whether the patient is active, on hold or inactive,in column 3912, the next delivery date that supplies will be deliveredto that patient 3914, a list of to-dos for the patient 3916 and clinicalstatus of the patient 3918. A clinician can access legend link 3920 tosee the meaning of the icons in to-do column 3916. The clinical status3918 displays information using icons from the clinician dashboard 3000(FIG. 30A). A clinician can also navigate to an add patient screen (FIG.41A) to add a patient by selecting add patient link 3922.

FIG. 39B illustrates an example screen shot of a legend screen pop-up3950 displayed on a clinician's display device 192. The legend screenpop-up 3950 may display a list of icons and their associated meaning.Pop-up 3950 is obtained by selecting legend link 3920. Icon 3952indicates an urgent to-do, icon 3954 indicates a non-urgent to-do, icon3956 indicates that the treatment was “Ok”, icon 3958 indicates a highpriority flag, icon 3960 indicates a normal priority flag, no iconindicates that no treatment was performed and icon 3962 indicates thatthere was no communication with the patient's therapy machine 100, suchas a peritoneal dialysis machine, on the associated date. A cliniciancan also hover a mouse cursor or pointer over to-do column 3916 inscreen 3900, which leads to pop-up 3960 (FIG. 39C) displayed on aclinician's display device 192. As illustrated in FIG. 39C, theclinician can see in pop-up 3960 that there are two to-dos for thepatient Jack Flash.

FIG. 40A illustrates an example screen shot of a patient informationscreen 4000 displayed on a clinician's display device 192. Patientinformation screen 4000 is accessed by selecting any one of the patientsin column 3904 of the patient list 3900 (FIG. 39A). The clinician canview information about the patient in patient information tab 4002,delivery information tab 4004 and additional contacts tab 4006. Theclinician can also view message 4008, which indicates that the patientinformation screen 4000 may be used to edit a patient's information. Aclinician can view and edit information about the patient, such as name,gender and birth date, in tab 4002. The clinician can also view and editclinical information related to the patient such as therapy modality4012, attending physician 4014, primary nurse 4016, patient billed to4018, diabetic status 4020, clinic patient ID 4022, gain reason 4024,and scheduled start date 4026, which is the patient's scheduled firstdate of treatment. The clinician can cancel or submit the information onscreen 4000 using cancel or submit buttons 4028 or 4030 respectively.The clinician can also return to patient list 3900 (FIG. 39A) byselecting view patient list link 4019. The clinician can likewisenavigate to various screens for viewing and editing data related to apatient by using view therapy information link 4021, view patient orderslink 4023 and add patient link 4025. The clinician can also navigate tothe patient snapshot (FIGS. 31A and 31B) via view patient snapshot link4027 and to the device settings (FIG. 33) via view device settings link4029.

FIG. 40B illustrates an example screen shot of the delivery informationtab 4004 of patient information screen 4000 displayed on a clinician'sdisplay device. Delivery information tab 4004 allows a clinician to viewand/or edit information related to delivery of supplies for a particularpatient. The clinician can also view and edit additional deliveryinformation that may make it easier to deliver supplies to a patient asillustrated in field 4032. The clinician can also specify the frequencyof delivery for a patient as indicated by drop-down 4034.

FIG. 40C illustrates an example screen shot of the additional contactstab 4006 of patient information screen 4000 displayed on a clinician'sdisplay device 192. The clinician can view and edit contact informationfor people related to or who otherwise support the patient in receivingsupplies and/or therapy. The clinician can specify an additional contactincluding the relationship of the contact 4036 and whether the contactis a primary contact using checkbox 4038 or a secondary contact usingdrop-down 4040. The clinician may also add or delete contacts usingbuttons 4042 and 4044 respectively.

FIG. 41A illustrates an example screen shot of an add patient screen4100 displayed on a clinician's display device 192 accessed by selectingadd patient link 3922 (FIG. 39A). The add patient screen 4100 displaystabs similar to the tabs in the patient information screen 4000 (FIGS.40A to 40C), such as patient information tab 4102, delivery informationtab 4104 and patient contacts tab 4106. The clinician can specifyinformation about the patient using tab 4102. FIG. 41B illustratesdelivery information tab 4104 of add patient screen 4100 displayed on aclinician's display device 192. Delivery information tab 4104 may beused by the clinician to specify the location and frequency ofdelivering supplies to a patient. FIG. 41C illustrates a patientcontacts tab 4106 in an example screen shot of add patient screen 4100displayed on a clinician's display device 192. Patient contacts tab 4106may be used by the clinician to specify the patient's contactinformation.

FIG. 42A illustrates an example screen shot of a therapy informationscreen 4200 accessible from view therapy information link 4021 (FIG.40A) and displayed on a clinician's display device 192. Therapyinformation screen 4200 displays therapy information tab 4202, solutionstab 4204 and disposables tab 4206. As illustrated in FIG. 42A, theclinician can view and/or edit a patient's therapy information intherapy information tab 4202. The clinician can view or edit a therapymodality 4208, the prescribing physician 4210, a purchase order number4212, a days reserve 4214 (which indicates how many days of reservesupplies the patient should have), a liters per day field 4216, a periodof effectiveness drop-down 4218, an effective date 4220 and anexpiration date 4222. The clinician can also specify the patient'shardware using drop-down 4224. The clinician can cancel or submit theinformation on screen 4200 using cancel or submit buttons 4226 or 4228respectively.

FIG. 42B illustrates an example screen shot of a solutions tab 4204 intherapy information screen 4200 displayed on a clinician's displaydevice 192. Therapy information screen 4200 is accessible from viewtherapy information link 4021 (FIG. 40A). The clinician can viewinformation about solutions that will be used by renal therapy machine100 at the patient's home. As illustrated in FIG. 42B, a clinician canview message 4230 that lists information about the solutions, such as amaximum quantity, days reserve and liters per day. The clinician canapply a template using drop-down 4232, which again allows the clinicianto enter preselected values for multiple parameters displayed on ascreen at once by selecting a template.

A clinician can also view the solutions that are used per line. In theillustrated embodiment, the clinician can view and edit informationabout two lines used for peritoneal dialysis, as indicated in column4234. Column 4236 specifies the solutions that are used in the lines.Column 4238 specifies the bag type for a line. Column 4240 indicates apercentage of glucose, column 4242 indicates a volume, column 4244indicates a frequency, column 4246 indicates units per frequency, column4248 indicates the number of days of reserve solution and column 4250indicates the maximum quantity of bags.

FIG. 42C illustrates an example screen shot of disposables tab 4206 intherapy information screen 4200 displayed on a clinician's displaydevice 192. Therapy information screen 4200 is accessible from viewtherapy information link 4021 (FIG. 40A). The clinician can view andedit information about disposables per line as indicated at column 4252and the product for each line at column 4254. Column 4256 indicates afrequency, column 4258 indicates units per frequency, column 4260indicates the number of days of reserve solution and column 4262indicates the maximum quantity for the disposable.

FIG. 43A illustrates an example screen shot of a patient order screen4300 displayed on a clinician's display device 192. Patient order screen4300 is accessible from view patient orders link 4023 (FIG. 40A). Thepatient order screen 4300 illustrates calendar tab 4302, order historytab 4304 and patient order tab 4306. The clinician can view a patient'scalendar information at tab 4302. Icons indicate events that occurred onspecific dates, such as icon 4308 that indicates that a phone call wasplaced on May 7, 2012, for example.

FIG. 43B illustrates an example screen shot of an order history tab 4304of patient order screen 4300 displayed on a clinician's display device192. The clinician can view at FIG. 43B the patient's order history,such as an order number in column 4310, scheduled shipment date incolumn 4312, order date in column 4314, ordered by information in column4316, purchase order in column 4318 and status in column 4320, such aswhether an order has been delivered, backordered, or not yet placed. Theclinician can also view additional details about an order using the viewdetails link in column 4322.

FIG. 43C illustrates an example screen shot 4350 of the additionaldetails that may be viewed by selecting the view details link in column4322 (FIG. 43B). As indicated in FIG. 43C, the clinician can viewinformation about the patient, delivery information, billing informationand patient product order quantities, such as the base products 4352,accessories that are part of the order 4354 and ancillary supplies thatare part of the order 4356.

FIG. 43D illustrates an example screen shot of a place patient order tab4306 of patient order screen 4300 displayed on a clinician's displaydevice 192. A clinician can use drop-down 4324 to place either astock-take order or a non-stock take order.

It should therefore be appreciated that the screens illustrated in FIGS.30A to 43D enable a clinician to efficiently and remotely manage therapyprovided by machine 100. The clinician can remotely order supplies andset prescriptions to remotely control machine 100 for providingtreatment to a patient, while still allowing the patient to controlcertain aspects of therapy. The screens enable the performance of thesefunctions efficiently and conveniently via the use of templates, andmake entering values failsafe because the clinician does not have todetermine whether values entered and selected are consistent with eachother. The clinician can also review logs documenting the treatments andbe alerted if certain conditions occur during the treatments. Thescreens are not limited to peritoneal dialysis and can likewise beimplemented in hemodialysis, hemofiltration, hemodiafiltration, CRRT,nutritional therapy or medical delivery of a drug.

Patient Portal

As described above, web portal 150 may be used by clinicians as well aspatients to access system hub 120. In one embodiment, web portal 150provides a patient dashboard that may be viewed on tablet 122 or on adedicated display device of therapy machine 100 at the patient's home.FIG. 44 illustrates an example screen shot of a patient dashboard 4400displayed on tablet 122 or dedicated display device of machine 100. Asindicated in FIG. 44, the patient dashboard 4400 displays a home tab4402, a your account tab 4404 and help tab 4406. In one embodiment, hometab 4402 provides information to the patient about the patient's supplyorders. In the illustrated embodiment, message 4408 indicates to thepatient that the next order is due from the patient in twenty-five days.A patient may place the supply order via link 4410. The home tab 4402also displays the patient's recent orders 4412 as well as a calendarview 4414 of the patient's order. The recent orders information 4412 inthe illustrated embodiment includes the dates and order numbers forrecent orders as well as the status of those orders, e.g., delivered orpending. The calendar of orders 4414 shows an icon on the day that theorder is placed, providing order status.

FIGS. 45A to 45G are example screen shots displayed on order screen 4500of tablet 122 or dedicated display device of machine 100. In theillustrated embodiment, the patient is currently on step 1, solutions,as indicated at item 4503. As indicated in FIG. 45A displayed on tablet122 or dedicated display device of machine 100, a patient can view atimeline 4502 listing the steps that the patient needs to complete toorder supplies. Cart icon 4504 inside of timeline 4502 indicates how farthe patient has proceeded along the order process. The patient isinstructed at message 4506 to enter the number of supply boxes remainingat the patient's home and the number of bags the patient uses per weekfor each solution. The home medical device system 110 then calculatesthe number of boxes that will be needed for the patient's next order.

Order screen 4500 displayed on tablet 122 or dedicated display device ofmachine 100 displays a chart 4510 of different types of consumables thatcan be ordered. A solution type column 4514 lists different types ofsolutions such as ultra bag solutions or cycler solutions. Column 4516lists fields for the number of boxes at the patient's home for eachsolution. Column 4518 allows the patient to enter in the quantity usedper week. The patient may use check box 4520 to populate informationinto the fields from previous orders. The patient can thereby save timeand conveniently order the same number of supplies as in a previousorder using check box 4520. As values are entered into columns 4516 and4518 in table 4510, renal therapy machine 100 calculates the number ofboxes to order as illustrated in column 4522. Alternatively, the patientcan press a calculator icon 4523, which causes renal therapy machine 100to calculate the number of boxes to order for column 4522. The patientcan then press the next link 4524 to proceed to the next step in thetimeline 4502, disposables.

Alternatively, the patient may be able to directly enter in thequantities of boxes that need to be ordered as indicated in message4506. Home medical device system 110 allows the patient to use his orher experience with a renal, nutritional or medical delivery therapy andits corresponding consumable and supply usage to ensure that thepatient's home is stocked with a sufficient quantity of consumables andsupplies. A patient can thus either provide information about thesupplies remaining in the patient's home and let home medical devicesystem 110 calculate the number of boxes that are needed, or the patientcan directly order a specific number of boxes. It should therefore beappreciated that the patient dashboard 4400 and order screen 4500provide flexibility as to how supplies may be ordered.

If the patient chooses to enter in direct quantities of boxes to orderby pressing link 4508 in FIG. 45A, the patient is then presented withthe example order screen 4500 displayed in FIG. 45B. FIG. 45Billustrates an alternative order screen 4500 displayed on a tablet 122or dedicated user interface for directly entering the number of boxes toorder. In contrast to the order screen 4500 displayed in FIG. 45A, whichallows a user to enter the number of boxes at the patient's home and thenumber of bags the patient uses per week for each solution so that homemedical device system 110 can calculate the number of boxes needed forthe patient's next order, order screen 4500 or FIG. 45B instead allowsthe patient to enter in the number of boxes to order directly. Thus inFIG. 45A, the patient enters values into columns 4516 and 4518 and inFIG. 45B, the patient enters values into column 4522.

FIG. 45C illustrates an example screen shot of order screen 4500displayed on tablet 122 or dedicated display device of machine 100. Item4525 indicates that the patient is at step 2, disposables as opposed tothe solutions of step 1. Timeline 4502 indicates that cart icon 4504 isin the disposables step inside of timeline 4502. On the screenillustrated in FIG. 45C, the patient can indicate the quantity ofdisposables he or she has at home and the number of boxes he or shewould like order for each disposable as indicated at message 4526. Asillustrated in FIG. 45C, column 4528 lists various disposables that maybe ordered, column 4530 allows the user to specify how many of thedisposables he or she has at home, and column 4532 allows the user tospecify the number of boxes he or she would like to order for eachdisposable. Check box 4534 again allows the patient to populate thefields with the values entered in previous orders, saving the patienttime in the event that the patient would like to order the same numberof disposables as in the previous order.

FIG. 45D illustrates another example screen shot of order screen 4500displayed on tablet 122 or dedicated display device of machine 100. Item4535 indicates that the patient is at step 3, ancillaries. Timeline 4502indicates that cart icon 4504 is also in the ancillaries step inside oftimeline 4502. Message 4536 asks the patient to indicate which ancillarysupplies he or she needs for the next order. As illustrated in FIG. 45D,the patient can specify the ancillary supplies needed by selecting anadd button, e.g., 4538, associated with the desired ancillary item. Thepatient can again populate this screen with previously orderedquantities using check box 4540.

FIG. 45E illustrates an example screen shot of order screen 4500displayed on tablet 122 or dedicated display device of machine 100illustrating that the user has selected to add ancillary items gauze andmasks as indicated by messages 4542 and 4544.

FIG. 45F illustrates a further example screen shot of order screen 4500displayed on tablet 122 or dedicated display device of machine 100. Item4545 indicates that the patient is now at step 4, review. Timeline 4502indicates that cart icon 4504 is in the review step along timeline 4502.On this screen, the user can review order details, select a deliveryaddress and confirm the order as indicated at message 4546. The user canedit an order item using edit button 4548 or remove an order item byusing remove button 4550. FIG. 45G continues the example screen shot ofFIG. 45F for order screen 4500. Here, the user can press button 4552 toplace the order.

FIG. 46A illustrates an example screen shot of a supply orderconfirmation screen 4600 that may be displayed on user tablet 122 ordedicated display device of machine 100. Confirmation screen 4600provides a message 4602 that the order is complete and recounts allitems ordered. FIG. 46B continues the example screen shot ofconfirmation screen 4600.

Additional Aspects of the Present Disclosure

Aspects of the subject matter described herein may be useful alone or incombination with any one or more of the other aspect described herein.Without limiting the foregoing description, in a first aspect of thepresent disclosure, a home medical device system comprising: a pluralityof home therapy machines that perform a home therapy on a patient; aconnectivity server; a system hub coupled to the home therapy machinesthrough the connectivity server; a web portal configured to access thesystem hub; a plurality of clinics connected to the system hub via theweb portal; and a website accessible via the web portal, the websiteincluding a patient portion available to patients using the plurality ofhome therapy machines, the website further including a clinician portionthat enables the clinics to manage the home therapy machines.

In a second aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the home therapy includes renal therapy.

In a third aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the renal therapy includes any one or more of hemodialysis,peritoneal dialysis, hemofiltration, hemodiafiltration, or continuousrenal replacement.

In a fourth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the home therapy machine is of at least one type selected fromthe group consisting of: (i) a hemodialysis machine, (ii) a peritonealdialysis machine, (iii) a hemofiltration machine, (iv) ahemodiafiltration machine, (v) a continuous renal replacement machine,(vi) a medical delivery machine, or (vii) a machine running anutritional therapy.

In a fifth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, each home therapy machine generates log files documentingtreatments performed by the home therapy machine and sends the log filesto the system hub through the connectivity server.

In a sixth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the connectivity server receives and stores data from theclinics until corresponding home therapy machines are turned on, afterwhich the data is transferred to the corresponding home therapymachines.

In a seventh aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the system is configured such that if the data transferredincludes a new device program, the patient for the corresponding hometherapy machine must accept the new device program before the new deviceprogram is performed by the corresponding home therapy machine.

In an eighth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the clinician portion of the website includes a therapyprescription screen for specifying supplies needed at the patient's homefor operating one of the home therapy machines.

In a ninth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the clinician portion of the website includes a device programscreen for setting parameters by which one of the home therapy machinesoperates.

In a tenth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the device program screen allows the parameters to be setdifferently in different device programs for the same home therapymachine and patient.

In an eleventh aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, at least one of the parameters is set as a range, and whereinthe patient is enabled to choose within the range for operation with thehome therapy machine.

In a twelfth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the device program screen allows for a template to be recalledfor populating a plurality of the parameters with preselected values.

In a thirteenth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the clinician portion of the website includes a patient settingsscreen, the patient settings screen enabling clinicians to set at leastone treatment display aspect.

In a fourteenth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the clinician portion of the website includes a cliniciandashboard including a list of patients; and a notification associatedwith each patient indicating whether a predefined treatment condition oralert occurred during a treatment.

In a fifteenth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the dashboard associates each patient in the list of patientswith at least one of (i) a treatment summary providing detailedtreatment data about the patient or (ii) a patient snapshot providinghistorical treatment data about the patient.

In a sixteenth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the system includes a product development client incommunication with the system hub, the product development clientcapable of providing a firmware upgrade that can be downloaded over thesystem hub and the connectivity server to the home therapy machine.

In a seventeenth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the system includes a service personnel director incommunication with the system hub, the service personnel directorenabled to approve the firmware upgrade for one or more of the pluralityof home therapy machines before the firmware upgrade is downloaded tothe approved home therapy machine.

In an eighteenth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the system includes at least one service personnel incommunication with the system hub, each service personnel dedicated toat least one of the plurality of home therapy machines, the at least oneservice personnel enabled to determine when the firmware upgrade, afterapproval by the service personnel director, is delivered to the at leastone dedicated home therapy machine.

In a nineteenth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the connectivity server is configured to provide a check that atleast one of (i) all data in a packet of data is actually sent or (ii)data is sent to the proper home therapy machine.

In a twentieth aspect of the present disclosure, any one, or more, orall of the first to nineteenth aspects may be used in combination withany one, or more, or all of the other of the first to nineteenthaspects.

In a twenty-first aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, a method for personalizing a therapy machine includes:generating a unique patient ID for a patient; generating informationabout the patient, the information including therapy machine settingsbased upon a prescription; and linking the therapy machine to thepatient by entering the patient ID and a second patient identifier intothe therapy machine, the linking causing the information to be sent tothe therapy machine.

In a twenty-second aspect of the present disclosure, which may be usedin combination with any one, or more, or all of the other aspectsdescribed herein, the therapy machine is a second therapy machine, andfurther comprising: providing a first therapy machine in a clinic;training a patient to operate the first therapy machine to perform arenal therapy in the clinic; and sending the second therapy machine tothe patient's home, the linking occurring after sending the secondtherapy machine to the patient's home.

In a twenty-third aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, a clinician enters the patient ID into the second therapymachine.

In a twenty-fourth aspect of the present disclosure, which may be usedin combination with any one, or more, or all of the other aspectsdescribed herein, the therapy machine is a second therapy machine, andwherein the linking is performed after a first therapy machine used by apatient malfunctions.

In a twenty-fifth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the second patient identifier is the patient's birth date.

In a twenty-sixth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the second therapy machine operates initially according to thetherapy machine settings.

In a twenty-seventh aspect of the present disclosure, any one, or more,or all of the twenty-first to twenty-sixth aspects may be used incombination with any one, or more, or all of the other of thetwenty-first to twenty-sixth aspects.

In a twenty-eighth aspect of the present disclosure, which may be usedin combination with any one, or more, or all of the other aspectsdescribed herein, a method for performing renal therapy at a home ordwelling of a patient using a renal therapy machine includes: retrievinga doctor's prescription for renal therapy; based on the doctor'sprescription, selecting supplies, including a dialyzer, at a firstlocation other than the patient's home; and sending the supplies and therenal therapy machine to the patient's home or dwelling.

In a twenty-ninth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, a method for performing renal therapy at a home of a patientusing a renal therapy machine includes: retrieving a doctor'sprescription for renal therapy; based on the doctor's prescription,selecting settings at a first location other than the patient's home ordwelling for operating the renal therapy machine; and performing renaltherapy on the patient according to the settings.

In a thirtieth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the method further includes: modifying the settings at the firstlocation for operating the renal therapy machine; and performing renaltherapy on the patient at the patient's home or dwelling according tothe modified settings.

In a thirty-first aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the settings include a parameter and an allowed range of valuesfor the parameter.

In a thirty-second aspect of the present disclosure, which may be usedin combination with any one, or more, or all of the other aspectsdescribed herein, the settings further include a patient editablesetting for the parameter, and wherein if the patient editable settingis enabled, the patient can modify the value of the parameter within theallowed range of values for the parameter.

In a thirty-third aspect of the present disclosure, any one, or more, orall of the twenty-ninth to thirty-second aspects may be used incombination with any one, or more, or all of the other of thetwenty-ninth to thirty-second aspects.

In a thirty-fourth aspect of the present disclosure, which may be usedin combination with any one, or more, or all of the other aspectsdescribed herein, a method for operating a home therapy machineincludes: performing treatment using the home therapy machine; storinglog files relating to the treatment; and using system communications tosend the log files to a connectivity server.

In a thirty-fifth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the method further includes: before performing the treatmentusing the home therapy machine, querying the connectivity server forupdated settings for the home therapy machine; and if updated settingsexist, sending the updated settings to the home therapy machine viasystem communications.

In a thirty-sixth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the method includes performing at least one post-treatmentoperation after storing the log files relating to the treatment andbefore sending the log files to the connectivity server.

In a thirty-seventh aspect of the present disclosure, any one, or more,or all of the thirty-fourth to thirty-sixth aspects may be used incombination with any one, or more, or all of the other of thethirty-fourth to thirty-sixth aspects.

In a thirty-eighth aspect of the present disclosure, which may be usedin combination with any one, or more, or all of the other aspectsdescribed herein, a method of upgrading firmware on a home therapymachine includes: generating upgraded firmware for a plurality of hometherapy machines; approving the upgraded firmware for the plurality ofhome therapy machines; uploading the upgraded firmware to a firstlocation; determining which of the approved home therapy machines shouldreceive the upgraded firmware; and for each home therapy machine thatshould receive the upgraded firmware (i) uploading the upgraded firmwarefrom the first location to a connectivity server associated with eachhome therapy machine that should receive the upgraded firmware; (ii)selecting a time to send the upgraded firmware to each home therapymachine that should receive the upgraded firmware; and (iii) sending theupgraded firmware at the selected time from the connectivity server toeach home therapy machine that should receive the upgraded firmware.

In a thirty-ninth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the method includes prompting each patient associated with thehome therapy machines receiving the upgraded firmware whether to installthe upgraded firmware.

In a fortieth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the method includes a determination by the home therapy machinesreceiving the upgraded firmware whether to install the upgradedfirmware.

In a forty-first aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the method includes prompting each patient associated with thehome therapy machines receiving the upgraded firmware to approveinstalling the upgraded firmware and a determination by the home therapymachines receiving the upgraded firmware whether the upgraded firmwarehas been approved.

In a forty-second aspect of the present disclosure, any one, or more, orall of the thirty-eighth to forty-first aspects may be used incombination with any one, or more, or all of the other of thethirty-eighth to forty-first aspects.

In a forty-third aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, a therapy entry, modification and reporting system includes: awebsite for displaying therapy entry, modification and reportinginformation; and a system hub for managing a flow of the informationbetween the website and a plurality of home therapy machines thatperform a home therapy on a patient, wherein the website includes atherapy prescription screen for specifying supplies needed at thepatient's home for operating one of the home therapy machines, a deviceprogram screen for setting parameters by which one of the home therapymachines operates, and a clinician dashboard having a list of patientsand a notification associated with each patient indicating whether apredefined treatment condition or alert occurred during a treatment.

In a forty-fourth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the device program screen includes a first parameter and asecond parameter, and wherein values that can be entered into the secondparameter depend upon values entered into the first parameter.

In a forty-fifth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the device program screen is a first device program screen, andwhich includes a second device program screen, wherein the firstparameter appears on the first device program screen and the secondparameter appears on the second device program screen.

In a forty-sixth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, a clinician's access to the second device program screen dependsupon values entered into parameters on the first device program screen.

In a forty-seventh aspect of the present disclosure, any one, or more,or all of the forty-third to forty-sixth aspects may be used incombination with any one, or more, or all of the other of theforty-third to forty-sixth aspects.

In a forty-eighth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, a method of verifying supplies used by a home therapy machinehaving a user interface includes retrieving a doctor's prescription forhome therapy; connecting a supply to the home therapy machine, thesupply including a code indicating information about the supply;obtaining the code using the user interface of the home therapy machine;determining the information about the supply from the obtained code;comparing the determined information about the supply with theprescription; and performing home therapy if the determined informationabout the supply comports with the prescription.

In a forty-ninth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the supply includes a container of a medical substance, whereinthe prescription includes a concentration of the medical substance thatshould be used in the home therapy, and wherein the code indicates theactual concentration of the medical substance in the container.

In a fiftieth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the supply includes a dialyzer, wherein the prescriptionincludes a type of dialyzer, and wherein the code indicates the type ofdialyzer.

In a fifty-first aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the user interface communicates wirelessly with the home therapymachine.

In a fifty-second aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the user interface includes a camera operable to read the code.

In a fifty-third aspect of the present disclosure, any one, or more, orall of the forty-eighth to fifty-second aspects may be used incombination with any one, or more, or all of the other of theforty-eighth to fifty-second aspects.

In a fifty-fourth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, a computer readable medium storing instructions is structured tocause a home therapy machine to: allow patient selection of aprescription from a plurality of prescriptions stored on the hometherapy machine; perform treatment using the home therapy machineaccording to the selected prescription; disinfect the home therapymachine; and generate log files documenting the treatment performed bythe home therapy machine.

In a fifty-fifth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the instructions are further structured to cause the hometherapy machine to: send the log files to a system hub; and query thesystem hub for at least one of (i) an update for one of theprescriptions from the plurality of prescriptions or (ii) a newprescription.

In a fifty-sixth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the instructions are further structured to cause the hometherapy machine to receive data from at least one of a water treatmentdevice, a weight scale, a blood pressure cuff, or a tablet.

In a fifty-seventh aspect of the present disclosure, which may be usedin combination with any one, or more, or all of the other aspectsdescribed herein, the home therapy machine is connected wirelessly to atleast one of the weight scale, the blood pressure cuff, or the tablet.

In a fifty-eighth aspect of the present disclosure, any one, or more, orall of the fifty-fourth to fifty-seventh aspects may be used incombination with any one, or more, or all of the other of thefifty-fourth to fifty-seventh aspects.

In a fifty-ninth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, a computer readable medium storing instructions is structured tocause a computing device to display a clinician user interface thatenables a clinician to manage a plurality of home therapy machines, theclinician user interface including (i) a device program screen forsetting parameters by which one of the home therapy machines performstreatments, and a clinician dashboard including (a) a list of patients,and (b) a notification associated with each patient indicating whether apredefined condition occurred during a treatment.

In a sixtieth aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the instructions are further structured to cause the computingdevice to store a first value entered into a first parameter on thedevice program screen, and determine, based upon the first value,whether a second value can be entered into a second parameter on thedevice program screen.

In a sixty-first aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the instructions are further structured to cause the computingdevice to store templates that can be recalled for populatingpreselected values into at least one of the device program screen, atherapy prescription screen for ordering supplies for one of the hometherapy machines, a patient settings screen for controlling howtreatments appear to patients, or a system settings screen forcontrolling settings other than how treatments are performed on the hometherapy machines.

In a sixty-second aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the instructions are further structured to cause the computingdevice to display a rules screen listing treatment events that can occurduring the treatments, store conditions related to the treatment eventsentered by the clinician into the rules screen, and evaluate log filesreceived from the home therapy machines based upon the conditions togenerate the notification.

In a sixty-third aspect of the present disclosure, which may be used incombination with any one, or more, or all of the other aspects describedherein, the instructions are further structured to cause the computingdevice to display an indicator indicating whether the same or adifferent clinician has reviewed the condition associated with thenotification

In a sixty-fourth aspect of the present disclosure, any one, or more, orall of the fifty-ninth to sixty-third aspects may be used in combinationwith any one, or more, or all of the other of the fifty-ninth tosixty-third aspects.

In a sixty-fifth aspect any of the structure and functionalityillustrated and described in connection with FIGS. 1 to 46B may be usedin combination with any aspect or combination of aspects listed herein.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

The invention claimed is:
 1. A home medical device system comprising: aplurality of home therapy machines each configured to perform a hometreatment on a patient at a home or dwelling of the patient, whereineach of the plurality of home therapy machines includes at least oneprocessor operating a connectivity agent; a connectivity server locatedremote from the home or dwelling of the patient, wherein theconnectivity agent of each home therapy machine enables the respectivehome therapy machine to communicate with the connectivity server onlywhen the connectivity agent is activated, and wherein the connectivityagent is deactivated during the treatment to prevent the home therapymachine from sending any data to or receiving any data from theconnectivity server during the treatment, and wherein after thetreatment is complete, the at least one processor activates theconnectivity agent; a system hub coupled to the home therapy machinesthrough the connectivity server, the connectivity server in datacommunication with the home therapy machines and the system hub; a webportal configured to access the system hub; a plurality of clinicsconnected to the system hub via the web portal; and a website accessiblevia the web portal, the website including a patient portion accessibleby patients using the plurality of home therapy machines, the websitefurther including a clinician portion that enables the clinics to managethe home therapy machines.
 2. The system of claim 1, which includes atleast one medical device in operable communication with at least one ofthe home therapy machines.
 3. The system of claim 1, wherein at leastone of the home therapy machines includes a wireless user interface. 4.The system of claim 1, wherein the home therapy machine is of at leastone type selected from the group consisting of: (i) a hemodialysismachine, (ii) a peritoneal dialysis machine, (iii) a hemofiltrationmachine, (iv) a hemodiafiltration machine, (v) a continuous renalreplacement machine, (vi) a medical fluid delivery machine, or (vii) amachine running a nutritional therapy.
 5. The system of claim 1, whereineach home therapy machine generates log files documenting treatmentsperformed by the home therapy machine and sends the log files to thesystem hub through the connectivity server.
 6. The system of claim 1,wherein the connectivity server receives and stores data from theclinics until corresponding home therapy machines are turned on, afterwhich the data is able to be transferred to the corresponding hometherapy machines.
 7. The system of claim 6, wherein the data transferredincludes a new device program, and wherein the system is configured suchthat the patient for the corresponding home therapy machine must acceptthe new device program before the new device program is performed by thecorresponding home therapy machine.
 8. The system of claim 1, whereinthe clinician portion of the website includes a therapy prescriptionscreen for specifying supplies needed at the patient's home or dwellingfor operating one of the home therapy machines.
 9. The system of claim1, wherein the clinician portion of the website includes a deviceprogram screen for setting parameters by which one of the home therapymachines operates.
 10. The system of claim 9, wherein the device programscreen allows the parameters to be set differently in different deviceprograms for the same home therapy machine and patient.
 11. The systemof claim 9, wherein at least one of the parameters is set as a range,and wherein the patient is enabled to choose within the range foroperation with the home therapy machine.
 12. The system of claim 9,wherein the device program screen allows for a template to be recalledfor populating a plurality of the parameters with preselected values.13. The system of claim 1, wherein the clinician portion of the websiteincludes a patient settings screen, the patient settings screen enablingclinicians to set at least one treatment display aspect.
 14. The systemof claim 1, wherein the clinician portion of the website includes aclinician dashboard including a list of patients; and a notificationassociated with each patient indicating whether a predefined treatmentcondition or alert occurred during a treatment.
 15. The system of claim14, wherein the dashboard associates each patient in the list ofpatients with at least one of (i) a treatment summary providing detailedtreatment data about the patient or (ii) a patient snapshot providinghistorical treatment data about the patient.
 16. The system of claim 1,which includes a product development client computer in communicationwith the system hub, the product development client computer capable ofproviding a firmware upgrade that can be downloaded over the system huband the connectivity server to the home therapy machine.
 17. The systemof claim 16, which enables a service personnel director to be incommunication with the system hub, the communication enabling theservice personnel director to approve the firmware upgrade for one ormore of the plurality of home therapy machines before the firmwareupgrade is downloaded to the approved home therapy machine.
 18. Thesystem of claim 16, which enables at least one service personnel to bein communication with the system hub, the communication enabling eachservice personnel to be dedicated to at least one of the plurality ofhome therapy machines, the communication further enabling the at leastone service personnel to determine when the firmware upgrade is to bedelivered to the at least one dedicated home therapy machine.
 19. Thesystem of claim 1, wherein the connectivity server is configured toprovide a check that at least one of (i) all data in a packet of data isactually sent or (ii) data is sent to the proper home therapy machine.